chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient called pharmacy this morning 11/12 to report an adverse reaction to her 2nd shot. Her first shot was at another pharmacy and she did experience excruciating pain down the arm and can't for sure remember but possibly also down her leg. She never reported that adverse reaction with the 1st shot..she just googled it and thought the shot might have been administered in the wrong location..the adverse reaction dissipated.  The adverse effects she received with the 2nd shot was bad dreams, and small welts that later coalesced into 1 welt measuring 4x2 and wrapping around her arm. She also states that it's so tender that she couldn't sleep on that side of the arm. When she filled out her paperwork she circled "no" to any adverse effects to the vaccine and also never mentioned it to the immunizing pharmacist. She said she will contact pharmacy if it doesn't resolveor get better in a couple of days.
it's a little bit itchy and bumpy and dry; a rash on the arm where received the vaccine; head aches that come and go, a head ache that never had before; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it's a little bit itchy and bumpy and dry), VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before). On an unknown date, the patient experienced PRURITUS (it's a little bit itchy and bumpy and dry). At the time of the report, PRURITUS (it's a little bit itchy and bumpy and dry), VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had advil as treatment medication.
Bilateral rash, itching, swelling, redness at site of injection; rash spread to right leg lower and upper back.
Blister like rash from each Pfizer shot.  Went to medical doctor tested several different things . Dx. Shingle Like Blisters  Rash after  each Pfizer dose X3. All over face, legs,  thighs
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). On an unknown date the patient deceived dose of VARIVAX that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA014687, MARRS#1405USA015420, MARRS#1405USA015422, MARRS#1405USA015423). Additional information has been requested.
62 year old female with obesity, NAFLD, DM, HTN, CKD stage V (not previously on HD), initially presenting on 1/13/22 for PD catheter placement, but tested positive for COVID (1/13) and referred to the ER 1/13 for further evaluation. Patient was mildly hypoxic during admission - she was noted to have pulmonary edema. She is vaccinated x2 and boosted. Oxygenation status improved to 95% after dialysis  which suggests pulmonary edema was likely the primary cause of hypoxia. She completed a dexamethasone course; remdesivir was held due to renal dysfunction. Her COVID isolation should end on 2/2. Her oxygen saturation was in the mid-90's on room air at the time of discharge.   Of note, patient had several chest xrays done during hospitalization that showed bilateral infiltrates/effusions; the last chest xray done before discharge (on 1/27) showed "improved upper lobe infiltrates and right pleural effusion; no significant change in the left lower lobe infiltrate/effusion." Patient will need chest xray as an outpatient to follow up on LLL infiltrate/effusion.
I got my second moderna shot yesterday and this morning I woke up feeling fatigued, dizzy, I have a headache and of course area where I got the shot is sore and swollen. Because of the arm pain I didn?t get the best sleep night.
Redness, hardness, warm feeling, sensitivity at injection site,  7 days after injection
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: This report was received via a chat. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) stated his patient was given SHINGRIX before the date of reporting and she had shivering since then. The health care professional (HCP) left chat before any additional information could be collected. No physical address was provided for HCP.
her antibodies are high; after getting the vaccines, she is feeling tired and lazy; after getting the vaccines, she is feeling tired and lazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 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 1, SINGLE), administration date: Jan2022, for COVID-19 Immunization, reaction(s): "she is feeling tired and lazy", "she is feeling tired and lazy". The following information was reported: LAZINESS (non-serious), FATIGUE (non-serious) all with onset 2022, outcome "unknown" and all described as "after getting the vaccines, she is feeling tired and lazy"; ANTIBODY TEST ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "her antibodies are high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller already had the 2 primary vaccines in Jan, she had not gotten the booster yet since then as her antibodies were high, they were now in Oct and her antibodies were still high. She was asking when she could get the booster, after getting the vaccines, she was feeling tired and lazy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 9 days after injection with no previous major symptoms, the injection site is swollen and red, very warm to the touch, feels firmer than the same location on opposite arm. Mild itching sensation.
Information has been received concerning a pt who was vaccinated on 09/29/1999 with varicella vaccine, MMRII, and IPOL. On 06/29/00 the pt developed a case of chickenpox with about 10 vesicles that was described as a mild case of varicella. The reporter indicated that she was unsure if pt had a fever or if exposure to a wild type. The pt sought unspecified medical attention. In 07/00 the pt recovered.
Patient describes the event as her arm being very sore that also radiates into her left clavicle  area and into her neck region.
Patient called and complained of large knot/ swelling, redness, and pain in site of injection.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
patient tolerated initial injection well.   approx 5 mins after vaccination the patient syncopized for 5 seconds while in the obs area.  caught by mother.  immediate recovery to normal cognition
Patient complained of itching of tongue, mouth, and lips.  Given po Benadryl 50mg, 40mg Pepcid po, and Xyzal 5mg po. Complained of hoarseness also.  Observed slight puffiness of lower lip.  Patient discharged 3 hours later.
While the patient was sitting in the waiting area, she passed out and began displaying signs of seizing, making nonverbal noises and convulsing. She quickly regained consciousness after approximately 1 minute of lost consciousness. The pharmacist on duty then asked the patient if she had eaten and drank today, to which she responded that she had not. The pharmacist then provided a granola bar and water.  The pharmacist also took the patient's blood pressure, measuring  92/58 mmHg with a pulse of 60 bpm. She then took a second reading 5 minutes later, measuring 112/68 mmHg. The patient quickly recovered and was able to leave without further medical attention.
Severe raised rash on upper chest. Severe rash on left side of face under eye. rash lighted up a bit by day 15. Moderate rash on backs of both arms, both legs. Still have mild rash on upper chest 23 days later. Rash was worse of left side of body in all areas.  I did not have any noticeable breathing issues, fever, etc. Arm did hurt within 7 minutes of shot and hurt very badly for 7 days. called my Dr friend and he advised me not to get the second shot. Said I had a reaction.
Patient called pharmacy at 11:15 am on 5/4/21 with complaint of lip numbness and shortness of breath. Told patient to call 911. Spoke with patient at 12:06 pm again, she stated the fire department came to her. They said her lungs sounded clear, take Benadryl and call them back if she is still having symptoms. She was not transported to the hospital. Recommended follow-up with her PCP +/or allergist and if warranted, and have 2nd COVID shot done in an MD office.
Second vaccine given 3/3 After 24 hours, patient began to feel exhausted and tired. After 48 hours, patient had 100.5 fever, Painful arm pit, Exhausted, Lymph Node Swelling, on the left side.  On 3/8 patient remains tired but feels like the symptoms are improving
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 5 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 25-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Initial effects included body aches and headache. The same symptoms were present the second day, only worse, with low-grade fever (99.8 maximum). Treated with a combination of ibuprofen and Tylenol.  Same symptoms persisted third day and included fatigue, requiring long nap. Symptoms lessened on the fourth day, but still caused slight fever and  body aches, which eased with 400 mg  ibuprofen.  There was also mild soreness at the point of injection, which was the left upper buttocks close to the hip.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 76-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Acute but intense fever, chills, and body aches. Had difficulty walking, sitting, eating, and using the restroom (physically, no internal issues like vomiting, constipation or diarrhea). Was more significant than any "real" flu I have ever had in the past. Could only sleep.   Symptoms decreased by the next day, but still fatigued.   Fully healed by third day.  *For clarity's sake, I had tested negative for SARS-COV-2 the day prior.*
I had headaches, chills, body aches, and dehydration symptoms starting at 3:00 am.  I took Tylenol 1000 mg and pedialyte on the first day. The second day my symptoms were minor headaches. I took Tylenol 1000 mg.
Achy, fever approximately 102 degrees F for 12-18 hrs. -took ADVIL.
Pt. reported having a headache and feeling light-headed after receiving HPV vaccine.  Pt. slid down in chair and fell over to the side, did not lose consciousness.  Nurse assisted pt. to lie down on cot and offered juice to drink.  Pt. was allowed to lie on cot for 20mins and reported feeling better.  Vitals taken, T - 98.8, BP - 110/78.  Pt. able to walk out with his cousin without assistance.
I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; This is a spontaneous report from a contactable consumer (patient, self-reported). A  female patient (age at vaccination: 28 year) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 06Jun2021, as a single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included gastritis. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had a lump on her collarbone (left side, same side as where she got her shot). It's tender and it felt like a ball that could move when she press on it on 07Jun2021. The patient did not receive any treatment for the events. Device date was 07Jun2021. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
Intermittent chest pain and tightness. Felt most strongly when sitting down.  Worst of pain/tightness subsided after a few months, but consistent 1/10 chest tightness still present and felt.
Weakness in arms and legs, unable to walk required lifting help, could not feed himself, confused, talking to himself, moaning while sleeping, increased fatigue, aching muscles and joints, chills, nausea, headaches, balance issues worse than normal.
Pt. received 1st dose Pfizer vaccine at 12:26 PM. Pt went to observation area for 15 minutes and offered water. At 12:34 Pt experienced syncope in waiting area and  fell from chair hitting their head on floor. Pt had a nosebleed. VS signs were BP 108/70, HR 72, RR 18, O2 99%. Pt was assessed by paramedics and taken to ED by ambulance. VS signs before he left were BP 111/72, HR 80, RR 18, O2 99%.
March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness  Three hours later a few minor sx began:- chills on my skin starting at hands, then pain across bottom of rib cage, then stabbing pains throughout torseau and legs-worsened at night time and joined by severe chills-shivering. All next day felt like I had flu-waking up most every hour-level 5-6 headache also developed. March 9th felt like I had the flu most of the day-flushing, then getting chills.  still stabbing pains and indigestion-very tender around ribcage (tender to the touch).  Took peptobismol tablet. Good 11-12 hour sleep 2nd night. Next morning:
Diagnosed with Bell's Palsy on Nov. 7, 2021 at Emergency room
17 y/o patient was administered vaccine (without parental consent) vaccinator verified name, dob , and id but did not realize patient was under 18 because they looked significantly older.  pt mom stated to rph that pt began getting hives while pt was sleeping on monday night, pt took benadryl but hives continue to worsen on tues, at which point the patient went to the hospital (ed) and patient was places on steroids.  weds pt mom called the pharmacy to let us know pt was vaccinated without parental consent.
ED visit for atrial fibrillation and then ED to hospital  for ICAO (internal carotid artery occlusion), Successful endovascular stent and aspiration assisted mechanical thrombectomy of right internal carotid artery terminus occlusion. Patient hospitalized and released.  ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Sneezing, congestion, headache, pain at injection site.  Slight upset stomach. Have taken acetaminophen and Sudafed.
Pfizer vaccine #2 ~10:10 AM 06/15/2021. ~3:00 PM gums felt inflamed. ~5:00 PM whole mouth inflamed/swollen, sore tongue and top of throat. No trouble breathing. ~4:00 AM 06/16/21 awoke to stomachache and thick sinus congestion; blew nose, tissue full of bright red blood. ~9:00 AM 06/16/2021: tiny blisters on still sore tongue, inside lips slightly swollen but worst subsided. Pain under left arm (injection arm). 6/17/2021 AM: All symptoms subsided except pain in left underarm. 6/18/2021 AM: Stil pain under left armpit. NOTE: Normal reactions: slight elevated temp and headache x 2 days. Took no OTC meds to avoid antibody interference. Stayed hydrated. Oura Ring showed significant sleep interference x 2 days.
The vial expired on 29-Jan-2022 and was stored in the refrigerator; A nurse administered 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The vial was initially stored in the refrigerator on 04-Feb-2022. The vial did not undergo any temperature excursions. Also reported dose administered after 30-day use by date or after manufacturer date of expiry. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contains no new information.
Initial misuse report received from a healthcare professional on 10 March 2014. The patient (No information was provided regarding the patient) had received expired dose of TD vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
shingles; At 48 years old the patient was vaccianted whit Zostavax; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 56 years old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approxuymatelly 08-SEP-2011, reported as "on or about  08-SEP-2011", the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for routine health maintenance for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).