chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & noticed the area was itchy & somewhat bumpy; denies that it was overly painful or warm; pt called the clinic & was told to come in;  presents w/3-4in circular area of red, raised bumps @ site of inj;
Pt is experiencing shoulder pain since injections. Has seen Dr. for pain. Shoulder X-ray done. Dr did not confirm pain from vaccine-Follow up 2/2017.
10/24/02 Felt tired with aches in PM following exercise (swimming). 10/25/02 Right arm with swelling and redness extending from site to wlbow on outer arm in 3" width; fever 101. 10/26/02 Redness worsened, site warm; fever down; felt better. 10/28/02 Still some redness, less swelling. 10/29/02 Some redness but no swelling.
Pt came in on 11/20/2018 saying that primary care doctor/pulmonary physician recommended getting PREVNAR 13 after receiving PNEUMOVAX a year prior due to his preexisting condition with bronchiolitis and prior surgery for a collapsed lung about 10 years ago. Patient was administered the vaccination and was observed for around 10 minutes before leaving with no symptoms. No allergies were noted. Around 3:00 pm patient's mother called back stating that patient had been coughing up a little blood. Contacted patient and noted that patient was not having any angioedema/allergic symptoms or trouble breathing or hived. Only notable symptom was the coughing up of blood. Advised patient to get checked out by emergency room due to coughing up blood. Advised doctor of the situation, which he said it could be due to his condition and not necessarily the vaccination. Patient at this time is getting check out at ER. Otherwise no notable other cardinal symptoms.
Late February 2022, started having pain in left leg, felt like pulled muscles going up & down my leg. Two months later after jogging I started coughing up blood & having chest pain. 3 weeks later was sent to the E.R. Diagnosed with Pulmonary Embolism
20jun89 pt vax hepta b. pt ex chest pain which persisted for few days. 03may90 pt vax 2nd hepta B. pt ex some chest pain.  27aug90 pt vax 3rd hepta B. w/ little or no chest discomfort.
This spontaneous report was received from a company field representative who refers to a female patient of unknown age. The patient's medical history and/or concurrent conditions were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23, (lot # and expiration date unknown). Concomitant medication was not provided. On an unknown date the patient developed redness and swelling at the injection site. The patient did not seek medical attention. Treatment was provided to the injection site in the form of an ice pack. The patient's symptoms resolved "within 24 hours". A PQC was not involved. No other information is available. Additional information is not expected.
rash on the lower part of chin; This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The patient received Shingrix and experienced rash on the lower part of chin. The reporter stated that, it looked like shingles but not confirmed.
102 degree fever, body aches, headache since 2/25/15 PM. Also felt dizzy. BP 118/70 T-97.1. R/O flu. R/O strep. pharyngitis. (P) cefdinir, TAMIFLU: Recheck 1 wk.
Parents report change of affect of patient -> seems "lethargic" per parent. Also c/o pain in left leg where he received vaccination. O/E patient had limited weight bearing on leg. No localized erythema or swelling.
Moderna COVID-19 Vaccine EUA Symptoms: fever of 101 degrees, bad body aches, nausea, sore arm , fatigue ; and this was first vaccine Had Covid 12-31-2020 and lasted 2 weeks with fever off and on
Client given expired Kinrix . Expiration date 9/30/22. No treatment needed. Client returned for revaccination on 11/1/2022.
no additional adverse effect reported; a patient was administered a dose of improperly stored PEDVAXHIB; This spontaneous report was received from a registered nurse and refers to 7-month-old patient of unknown gender. No information regarding drug reactions or allergies and concomitant therapy was provided. On an unknown date, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).  On 18-FEB-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscularly, lot # S023219 has been verified to be a valid lot number, expiry date: 03-MAR-2022, for prophylaxis (dose number was not provided). No adverse effects reported. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit for 2 hours and 15 minutes. There were no previous excursions related. Data logger was involved.
Patient reported history of syncope with shots/blood draws in the past. After shot was given, patient stated that she felt light headed and bent over on the chair with her head between her knees. She began to snore and so I rubbed her back to wake her up and she came to almost immediately. She then alternated between sitting upright and hunched over on the chair while I continued to fan her as she was feeling warm. After 15 minutes she started feeling better and was able to call a friend to come pick her up at the pharmacy. She also asked for some water. At this point, she was sitting upright and was on her phone for another 15-20 minutes before her friend arrived and she left on her own strength
This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # reported as M005921; expiration date, site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
On October 25, 2017 I was given my flu shot. On November 6, 2017 around 11:30pm, i was awoken by sharp, stabbing pain by my ribcage moving upward towards chest. I went into the living room and had taken aleeve, zantac, and pepto bismol. Shortly after taking the aleeve, I used my inhaler to help with shortness of breath and thereafter, i felt tingling in my hands, feet, and face. The tingling turned into paralysis where i could not move my hands, legs, and my shortness of breath continued. I called 911 and within 30 mins, i was able to control my breathing and the tingling went away only in my hands and NOT my legs. I was taken to the hospital by ambulance. When i arrived at the hospital, i could not longer move my hands, legs and arms. I had shortness of breath, i could barely speak and ER staff immediately intubated me and began running tests.
Wrong vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administered). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administered) had resolved.            No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was  not applicable.
vaccine received 11/2pm. 11/3 had significant fatigue. 11/4 had severe nausea. 11/5 awoke with severe body aches, severe headache, severe nausea. Though I wore my CPAP all day, I began grunting mid morning and when I finally thought to check my O2 it was 84% on RA with CPAP on. I was evaluated in ED and cleared of PE and all viral respiratory illnesses.
Patient and mother went to Doctor after immunizations. Patient complained of itching feet. Mother noted rash ankle and below bilateral. As time progressed hands itched and a small patch of rash noted on back. Mom gave Benadryl and used hydrocortisone cream with relief. Patient had temp but mom did not check it. Right upper arm swollen and reddened. ibuprofen given.  Very little rash today.
Vaccine administered after expired. Dispensed from pharmacy 8/18/2022; given 8/19/2022. No symptoms reported.
Sub Q injection (R) lateral thigh developed 4-5 cm area of induration, pruritic.
Patient received the vaccine around 9:38 AM and was placed in a chair for observation. Within 3 minutes the patient had fallen onto the floor on his side out of the chair. The pharmacist on duty at the time myself ran over and asked patient if he was ok and touched his shoulder. The patient regained consciousness and was moved to the vaccination room and put feet up for evaluation. The patient loss consciousness for 10 more seconds. Vitals were taken immediately (see below) and patient was interviewed for adr's. Patient had extreme diaphoresis, said he had no diplopia but did have blurred vision . Patient said his head hurt and was given 500 mg apap for one dose. He said his ears were hot. Patient said he had no pain other than his head hurting. Patient had no uticaria or redness . Patient appeared pale. He was given extensive amounts of water and a snack. He said that sounds were slightly muted. He said he had senstivity to lights.
At 4PM leg noted to be swollen like golf ball at injection site. Left thigh reddened and hot to touch and hardened next AM. Swelling down some, hardness and redness continue. Day 3 area red and hard to touch, no swelling. Day 4 area still hardened, no redness or swelling.
pt had vax 2wk ago (around late October) & devel GBS, numbness, tingling sensation in  B/L LE & UE, generalized weakness, diff ambulating, tachycardia, pt adm to hosp;dx GBS
Stye infection on left eye lasted 5 days. Appeared only 3 days after the vaccine and I had no previous history of Stye infections prior to this. I was vaccinated on my left arm and the Stye appeared on my Left Eyelid.
After receiving initial dose of Pfizer vaccine, patient reported feeling faint. Denied any other symptoms. Patient laid in supine position. Ice packs applied. Water and snacks provided. Vital signs stable. Patient monitored for a total of 35 minutes. Patient reported having no symptoms upon leaving.
Approximately ten minutes following administration of GARDASIL #2, patient experienced erythematous blanchable macules on both arms. Denied SOB, nausea, itching and/or pain. No reaction following GARDASIL #1. Rash began to resolve with no treatment except BENADRYL, 25 mg.
Cramping; urgency; Either liquid or extremely soft stools; Weight loss; Inability to eat; Chose not to get a Moderna vaccine, but in early May got Johnson and Johson; Diarrhea/ Urgency; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools) and WEIGHT DECREASED (Weight loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea/ Urgency). In May 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson). On an unknown date, the patient experienced ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss) and EATING DISORDER (Inability to eat). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form twice a day. At the time of the report, DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss), EATING DISORDER (Inability to eat) and INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The vaccine Batch/Lot number was updated. New events were added.
flu like symptoms; difficulty breathing; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history provided by the patient.  Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (difficulty breathing) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of the Moderna Covid 19 vaccine (Lot: not provided, expiration:unknown) on 10APR2021. Two days after administration of the shot, patient started to experience flu like symptoms, fever and difficulty breathing. She received her first dose at PCAT college. Patient is currently taking Vitamin B and Vitamin C. Patient does not have a primary care physician. Patient provided consent for Safety team to contact her on her phone number Treatment information as not reported.
Patient was seen on 10/12/2018 for her month well child check. She was growing well and had a normal physical exam. Vaccines given a 0930. Developed 1 episode of vomiting later that evening but continued to nurse well. Felt febrile to mother about 16 hours after receiving vaccines, temperature was taken and was 104.7 and rising per mom. She was immediately brought to Hospital ED, ED reports initial temp of 38.6 C. She was alert with a social smile. Pulse ox 99% RA, Resp 26, pulse 147. Exam revealed no source of fever. Labs were done. Patient was D/C with a Dx of febrile syndrome. On 10/14/2018 mom felt she was lethargic. Temp taken was 96-97 F. She was bundled and warmed and T returned to normal that day. Patient was seen in our office on 10/15/18. Her exam then was normal and she appeared well. She was seen on 12/20/18 for her 6 month PE growth and development were age appropriated and normal.
After 3/02/11 vaccine developed fever 103 gave MOTRIN. Rash developed 1 week later gave steroids. Has not slept well since. He started vomiting - seen by GI - Dx with failure to thrive. No dx or reason (child healthy before vaccine).
I had a reaction to it in my left arm & that night my right hand started trembling; I had a reaction to it in my left arm & that night my right hand started trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "I had a reaction to it in my left arm & that night my right hand started trembling". The patient received the first round of the double Covid vaccine back in Jan2021 and had a reaction to it in the left arm & that night, the patient's right hand started trembling, so when the patient went for the second, the on-hand pharmacist had the patient receive it in the right arm. In Aug, the patient had the Delta variant and couldn't get out of bed, 2022 Covid, 2023 Covid. The patient stated it's like the patient have no immune system anymore thanks to the vaccine and the patient's body just keeps getting weaker and weaker. Doctors are no help. The patient stated, ''Long Covid is killing me.''  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Information has been received from an RN concerning a pt (demographics unknown) who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (from either lot 641532/1353L or 641130/1161L). Subsequently, the pt developed an injection site reaction that involved "one-half the circumference" of the arm. The pt sought unspecified medical attention and was treated with an antibiotic. The reporter expressed a concern with the lots. Additional information has been requested. A 15-day follow report received 8/5/2003 adds: She developed pain and swelling of the right arm and was seen by the physician on 05/31/2002. At the time, she had right upper arm swelling, erythema, and tenderness involved 2/3 of the upper arm. The erythematous area extended from her shoulder to 2 inches above the right elbow. Laboratory testing revealed the following: WBC and blood culture normal. The pt was treated with an antibiotic. On 06/07/2002, the white blood cell count was noted as normal, the right upper arm erythema and swelling had resolved, and there was a "little bit" of pain. The reporter indicated that there was "no notation of any further problems in following office visits." The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between later December 2014 and early January 2015, the patients were vaccinated with improperly stored ROTATEQ oral. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This morning we vaccinated a 13yo with our inventory of Pfizer Bivalent, Lot# GL0087. We received this shipment on 12/6/2022. In CIIS, the inventory expiration date was incorrectly inputted as 08/31/2023 - it should have been 10 weeks from 12/6/22 since we store it in the fridge. Making the expiration date actually two weeks ago 2/14/2023. The patient did not show any s/sx of adverse reaction at the clinic.
Tingling in  fingers of left hand.  Muscle in upper left arm  pulls when moving arm a certain way.
This is a spontaneous report from a contactable consumer (friend of parent of the patient). A 4-months-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. On the same date the patient received other unspecified vaccines. The patient medical history and concomitant medications were not reported.  The patient developed a very high fever within a few hours. In addition, later that evening he developed spots on his torso, which turned out to be a rash the following day. The outcome of the event was unknown. The patient experienced similar events with the third month shot (unspecified vaccine). Information on the batch number has been requested.
Approximately two days after receiving my booster I noticed a tender feeling around my collarbone. I then felt that the supraclavicular area appeared to be filled with fluid and swollen. It was noticeably swollen to the point it was hard to see my collarbone.  It is currently still swollen though seems slightly less fluid-filled.
I have cough, short of breath,  want to throw up. Tight chest, chest pain, trouble focusing, dizziness right after I get the shot.   Tight chest and short of breath last for long I still have it now and coarse voice,  yesterday. Today my throat feels swollen chest stomach pain and tight from the back to the from around Rhomboid  region yesterday is right side tot day is left.. still feel short of breath right now.  And stuffy nose
pt fell to ground @ clinic w/tonic clonic movement of all 4 extremities, eye rolling, negative urine or stool incontinence;
When it was administered, its content was very little compared to those of her colleagues; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues). On 01-Apr-2021, ACCIDENTAL UNDERDOSE (When it was administered, its content was very little compared to those of her colleagues) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient thought that it was not completely complete dose.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Accidental Underdose for mRNA-1273 (Lot #: 007B21A)  with no associated AEs.