chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report refers to one or more of 8 to 10 patients of unknown gender and age. Information was received from the registered nurse. She stated that PROQUAD (Merck) lot # J001052, expiration date: 28-JUL-2014 was stored in refrigerator 36F to 46F up to the middle of August. Improperly stored PROQUAD (Merck) was administered to one or more of 8 to 10 patients on 02-AUG-2013. No symptoms were reported. This case is linked with MARRS # 1310USA000175 MARRS # 1310USA000177 and MARRS # 1308USA014956 (Same reporter link). Additional information has been requested.
Initial unsolicited report was received from a consumer who is also the patient on 19 November 2014. A 21 year-old male patient had received on an unspecified date an Influenza vaccine (manufacturer, lot number and administration details not reported) and an unspecified amount of time later, experienced the flu and was in bed for two weeks. No further information was available at the time of the event. Outcome was unknown. Documents held by sender: none.
The pt developed fever to 103 degrees F two days after the vaccine administration. Sepsis workup grew no bacteria. By day two, he was eating well and etiol of  illness unclear, no seizure, no obvious residual.
I received my shot and we drove to the parking waiting area. By the time we got to the person to tell us where to park I was feeling very light headed. My heart felt like it was racing and I felt like I was going to faint. This was about 2-3 minutes after receiving the shot. The woman told us to park near the EMS tent. We parked and about a minute later I started feeling better. It took about 10 minutes in all to feel completely fine again. I did have a bowl of cereal for breakfast that morning before we left for the appointment, so it wasn't low blood sugar due to an empty stomach. I did call my doctor, but I have not seen him as of yet.
COVID-19 vaccine administered 9/15/2023. Patient developed bruising 4 days later. Severe thrombocytopenia recognized 10/10/2023 with platelet count <5000. Patient remains admitted at Hospital for thrombocytopenia refractory to dexamethasone 40 mg daily x 4 days, IVIG x 2, and Rituximab.
Diarrhea. Tachycardia HR > 100bpm. Redness below injection site. Flu like symptoms.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included 12 VITAMINS for an unknown indication.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-027951 (Patient Link).
Pain in side under rib approximately 20 minutes after immunization , fever, frequent bowel movements. all symptoms lasting four days.
Lightheaded immediately and almost passed out.  Felt a tingling in both hands.  Metallic taste in mouth for about an hour.  8 hours later had the chills, body aches, headache, sinus pressure, and blocked ears.  I developed tinnitus in both ears 24 hours after the shot and it still hasn't resolved 16 days later.
administer an expired Flublok with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (GMI) (Reference number- 00530251).  This case involves a adult female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ446AA, expiry date: 18-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on 22-Mar-2021 (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX-23) for Immunisation.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient came in for a shingles shot, but was accidentally given a covid shot.  Patient had already received 2 doses of Moderna on 3/9/21 and 4/6/21, so this was his third dose of the covid vaccine.  The patient said he felt a little dizzy and a little tired and I will be following up with him and his daughter  over the weekend.
Pt said broke out in rash the week of Oct 8th which is the week she got her flu shot. She said she didn't think anything of it but it kept getting itchier and spreading. She finally went to the doctor on 11/6/07. Doctor says that is the only thing they can figure it was from.
Approx 1 week after receiving the vaccine patient developed a red rash around the injection site and extending halfway down the upper arm. Patient reported rash was warm to the touch. Patient went to urgent care and was given an antibiotic for presumed cellulitis.  After 24 hrs on antibiotic, rash reportedly improving.
5 patients received a full dose vial (3.0 ml exconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints.  This patient was identified as one of the possible recipients.
Developed itchy red rash on trunk which is still active after treatment by two dermatologists, allergist and primary doctor
Shingles light case; hives, blisters, rash all over both arms. Swelling of both arms. All of these lasting 5 days. Treatment: BENADRYL and calamine lotion.
about 10:30 am MMR was given on left arm SQ and monitored for 15 min, at about 11:00 am patient returned complaint was itching all over body developing mild rash, swelling of upper lip and right ear swelling and redness. at 11:05 first Epi was given then dose of Benadryl was also administered area was massaged at this time 911 was called and patient was monitored at 11:10 patient continues to complain of itchiness and swelling of lip and second dose of Epi administered and 11:25 am EMS arrived and resumed patient care. Patient to follow with Benadryl q 6h po  prn.
FREEZING COLD; HEAD WAS COLD LIKE ICE/SEEMED LIKE DYING; WHOLE BODY COULD NOT MOVE; SHAKING; SORE ARM; NO ENERGY; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced no energy. On 18-APR-2021, the subject experienced freezing cold. On 18-APR-2021, the subject experienced head was cold like ice/seemed like dying. On 18-APR-2021, the subject experienced whole body could not move. On 18-APR-2021, the subject experienced shaking. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from freezing cold, head was cold like ice/seemed like dying, whole body could not move, and shaking, and the outcome of sore arm and no energy was not reported. This report was non-serious.
hurt like hell, rolled around on bed for 3 days; rolled around on bed for 3 days and cried; rolled around on bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mom had shingles, it was awful).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, malaise and crying. On an unknown date, the outcome of the pain and crying were unknown and the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the pain, malaise and crying to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had first Shingle shots hurt like hell, the second one almost nothing.  The patient was rolled around on the bed for 3 days and cried and the patient stated he/she would still get it again.  Additional Supportive Information: This case was linked with US2022AMR132568, reported by same reporter. Follow-up would not possible as no contact details were available; Sender's Comments:  US-GSK-US2022AMR132568:Same reporter
Pt stated about an hour-hour and a half the room began to spin. Pt was sitting in a car at the time. States she felt like was going to pass out. The feeling eventually went away. Pt called following day to inform us of occurrence. Stated that next day she was feeling well with no complaints but thought we should know about her near-syncopal episode. Patient was advised to follow up with her PCP to ensure there isn't any other health condition and to ensure pt's health and safety. RN.
PUNCTURED VACCINE WAS ADMINISTERED TO PATIENT PAST THE 6 HOURS STABILITY WINDOW; This spontaneous report received from a pharmacist concerned a 77 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021 13:00, the subject experienced punctured vaccine was administered to subject past the 6 hours stability window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vaccine was administered to patient past the 6 hours stability window was not reported. This report was non-serious. This case, from the same reporter is linked to.
Arm was sore; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Arm was sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was sore was unknown.
Fever, chills, body aches, headache. Lymph node in right armpit swollen to size of a baseball. Have not received treatment.
First shot: diarrhea, nausea, vomiting, dizziness, fever w/ chills. 5 hrs after getting the shot. 2nd shot: same as above w/ hives - inability to move her arm.
got covid; got covid; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE , dose 2 on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got the Pfizer vaccine, got covid, got the second Pfizer dose, got covid, and his symptoms were 10 times worse with the second dose. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, redness, extreme irritation to Left arm post PPV23 vaccine. Patient reported to ER that evening for major reaction, fevers and chills post ER visit.
I don?t know which flu vaccine I received, but the injection hurt way more than any other vaccine I?ve ever received. Driving home immediately after the appointment, the veins in the side of my neck hurt.  Then my should hurt a lot when I moved my arm upwards. It was not the typical muscle soreness that I?ve experienced with other vaccines. By the time I got home, about 20 minutes later, the neck pain had subsided.  I then noticed the bandaid was on the top of my shoulder, not my deltoid muscle.  The pain in my shoulder when I move it up and across has not subsided in all this time - I cannot get undressed on my own because I can?t lift my arm to pull my bra or shirts off, for example.
SEVERE ASTHMA ATTACK TREATED WITH 9 PUFFS OF PROAIR HFA RESCUE OVER 5 MINUTES
This is spontaneous case, initially received on 23-Apr-2018, reported by a pharmacist and concerns a 22-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Oct-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 179904P, expiry date: 31-May-2018). On 16-Dec-2017, the patient was inadvertently administered with FLUVIRIN (dose 0.5ml, route of administration: intramuscular, batch number and expiry date were not reported) as the pharmacist did not know that the patient had already received the flu shot for the season (inappropriate schedule of vaccine administered). And also, the second vaccination was not done at the same pharmacy where the first vaccine was received. The patient did not experience any adverse effects.
Hospitalized for chest pain in the setting of COVID remdesivir initiated due to immunosuppressive therapy.
Approximately 3 hours after vaccines were administered, patient became very fussy and had erythema and swelling on the left thigh at the site of the PCV13 vaccine. Mom was able to soothe infant to sleep. Three hours later, the swelling and redness increased in size to about 3-5 inches in diameter, and infant was inconsolable. Mom gave tylenol and cool compress. Three hours later, the erythema and swelling had resolved.
Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Injection site: soreness, rash/warmth/itchiness; Tiredness; This is a spontaneous report from a contactable healthcare professional, the patient. This 28 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284 ),  dose  1 , single dose via an unspecified route of administration in the left arm on 06Jan2021 at 12:00 PM (at the age of 28 years-old) for COVID-19 vaccination.  There was no relevant medical history reported. The patient had allergies to non-steroidal anti-inflammatories (NSAIDS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam, lacosamide (VIMPAT) and pantoprazole. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 06Jan2021 at 12:00 PM, the patient experienced injection site soreness, rash/warmth/itchiness and tiredness all improving over 3 days. The report was reported as non-serious. The patient was treated for injection site soreness, rash/warmth and itchiness with acetaminophen. The clinical outcome of injection site soreness, rash/warmth/itchiness and tiredness was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt says he felt dizzy, had a slight fever, headache, nausea, no appetite starting the day after the shot was administered. His arm was also sore. The effects lasted for about 4 days. He says that the same happened with the 1st SHINGRIX vaccination on 03/17/2018, but the effects only lasted about 2 days. This time it took him longer to recover. He did not report the side effects after the first shot at the time.
pt recvd vax & devel d & looked pale; redness & swelling in area of inject; d cont for 24 hrs;
Pt was given Varicella and MMR on 10/27/14. On 10/28/14, she returned to clinic with a rash on abdomen/back/face. Mild redness at vaccine site.
Headache; nausea; vomiting; chills; sweats; things smell and taste off; things smell and taste off; This is a spontaneous report from a contactable consumer reported for herself that. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:45 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 61 years). The patient past Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing 50 plus years rheumatoid arthritis high blood pressure from an unknown date and unknown if ongoing, digestive issues from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing  and fibromyalgia from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for an unspecified indication, venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, omeprazole (OMEPRAZOLE) taken for an unspecified indication, pravastatin (PRAVASTATIN) taken for an unspecified indication and gabapentin (GABAPENTIN) taken for an unspecified indication.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. The patient previously took morphine and experienced drug hypersensitivity. On 14Mar2021 16:00, the patient experienced headache, nausea, some vomiting, first night of symptoms, chills and sweats, things smell and taste off. No treatment was received. The event outcome was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
I got my vaccination in September and I developed influenza B in November.  I coughed non stop for about two weeks and sort of lingered for quite a while. Since then, I've had more problems with coughing. The biggest thing that I have noticed is that I get really short of breath when I'm walking. When I climb stairs it feels like I'm dragging my behind behind me and it takes me a while to catch my breath. I also have been experiencing a lot of fatigue. I do take a lot of medicine so I don't know if the fatigue is from the medicine or related to this but it has definitely become more prevalent in the last few month. I'm not accomplishing much, I can't exercise like I used to. I've gained a lot of weight and used to be a smoker, as well. I've had an echocardiogram and I have an order for a chest XRay probably next week. In June I have a breathing test scheduled and after all the results are in I will see a pulmonologist. When at the pulmonologist for the Echo, they had me do a 6 min walking test to look at my breathing. My oxygen levels were fine but I was clearly out of breath. I did have a lung screening before I had influenza because I was a previous smoker, and that was clear.
fever & body aches started 1hr p/vax;mom did not mention pt had fever & body aches x 2 days p/vax given 4/23/99;
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 25-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA007631: US-009507513-1710USA013408: US-009507513-1710USA013406.
Chest pain, high blood pressure, palpitations, fatigue, weakness, heart arrythm, Joint pain, muscular pain, hearing loss, visual disturbances, high cholesterol. Listed diagnoses are chronic tobacco abuse, Alcohol abuse, cardiomyopathy, Diabetes Mellitis, and depression.
Post vax, right deltoid became red, itchy and with 50 cent-sized induration. PO Benadryl taken. Thirty minutes later, "throat feels swollen and harder to swallow". Escorted to ER in hospital (next door) and they were too busy to see her for 1/2 hour. She worked at the clinic. Symptoms subsided with no reoccurrence.
Tues. March 16 10:20 am - Received shot.    Tues. March 16 11:00 pm - Started feeling tired, achy, and started having chills.   Went to bed. Felt like I had fever, but did not take temp.  Wed March 17 Throughout early morning - same symptoms except no chills anymore.  Fever varied from 99.5 - 100.   Wed. March 17 - Throughout day and evening - Too weak to function, fever in morning, not in afternoon, when getting up weak and had to go back to bed.  Thursday, March 18 3:00 -3:30 am Running fever 99.5 - 100.1 with mostly just headache.  Thursday, March 18  7:00 am Woke up with sweat and temp. was gone.
Initial report received from a health care professional on 20 March 2012. This reporter also reported other adverse events, which captured in case number 2012-02851 and 2012-03162. A female patient (age not reported) received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C4063 and sanofi pasteur Inc. lot number U4308BA, on an unknown date. The patient became diaphoretic, cold, clammy, blood pressure elevated, throat itching and narrowing and was anxious. The outcome was not reported. Documents held by sender: None.
Severe Congestion, Sore Throat, slight nausea lasted for 2 days, then rewsolved. Patient came down with hives on 10/04/2009 in the AM. Taking benadryl
21FEB99 inc temp, congestion, cough, APAP;flu dx;
She received 2nd dose of covid vaccine (Moderna) 3 days prior to DVT.