chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could not breathe very well; trouble breathing; Bad headaches; Really bad muscle; Muscle very sick; lack of energy; super achy; Quite achiness in fingers; hurts a lot; Very sore arms for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Could not breathe very well; trouble breathing"; HEADACHE (non-serious), outcome "unknown", described as "Bad headaches"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "Really bad muscle; Muscle very sick"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Quite achiness in fingers; hurts a lot"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Very sore arms for 5 days"; ASTHENIA (non-serious), outcome "unknown", described as "lack of energy"; PAIN (non-serious), outcome "unknown", described as "super achy". Additional information: Consumer stated, "I have concern that just had a terrible reaction, I could not breathe very well, super achy, super bad headaches, fingers hurt a lot really bad muscle, I have for 5 days. you know some tough reaction from the vaccine, they are some of the reactions with the vaccine." When paraphrased the concern: Consumer stated, "Muscle very sick, quite achiness in fingers hurts a lot, trouble breathing, and it would not away from 5 days. Terrible Headaches, trouble aching, trouble in breathing, very sore arms for 5 days and lack of energy."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Information has been received from a physician, concerning a 73 year old female pateint, who on 06-OCT-1995 was vaccinated with the first dose, 0.5ml, IM, of Pneumovax 23, and on 22-MAY-2007 was vaccinated with the second dose, 0.5ml, IM, of Pneumovax 23. Concomitant therapy included vitamins (unspecified) and calcium (unspecified). On 22-MAY-2007, following the second vaccination, the patient experienced soreness, erythema, swelling and warmth around injection site on her left upper arm. The pateint took Benadryl and applied cold compresses to treat the symptoms. On 24-MAY-2007, the physician saw the patient, and reported her left arm was then swollen from her upper left to the mid part of her forearm, and continued to be red and warm, and had become painful with decreased mobility. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) on 16-JUN-2011 and second dose on 02-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
2 days after, woke up with right sided chest pain.  Pain made worse with stretching or bending forward.   Chest xray and labs pending.   Pain has started to improve since it started.   Advised that if pain worsens, to go to hospital.
This spontaneous report was received from a registered nurse who read a life story of a 16 year old patient on a website called "Inspire". On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced headaches after vaccination. The outcome of headaches was unknown. This is one of the several reports received from the same source. Additional is not expected.
Active urinary tract infection after booster dose but before 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose). At the time of the report, URINARY TRACT INFECTION (Active urinary tract infection after booster dose but before 2nd booster dose) outcome was unknown.            No concomitant medications were reported. The patient had received primary vaccination series and booster - Moderna. No treatment information was reported.   Reporter did not allow further contact
red; itching; pain at site; rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (pain at site), VACCINATION SITE RASH (rash on arm), VACCINATION SITE PRURITUS (itching) and ERYTHEMA (red) outcome was unknown.            No concomitant products reported. Benadryl was used as a treatment product. Action taken with mRNA-1273 in response to the events was Not Applicable.     This case was linked to MOD21-051781 (E2B Linked Report).; Sender's Comments:  MOD21-051781:cross link
Initial report received from a pharmacist on 23 October 2013. A 66 year old female patient had received FLUZONE HD (lot # U4785AA and expiration date unknown) intramuscular (IM) on lef6t deltoid on 16 Oct 2013. On 16 Oct 2013, the patient was having sweats, chills, nausea and a temperature of 99 Fahrenheit for approximately 24 hours after vaccination. Medical history includes allergy to Naproxen (Aleve). The patient was recovered at the time of this report. No further relevant information reported.
Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), first dose on 25Mar2021 08:00 (Lot number: EP7534) and second dose on 15Apr2021 (Lot number: ER8737) both via an unspecified route of administration, administered in right arm as single dose for COVID-19 immunisation. Medical history included RSV (respiratory syncytial virus) autoimmune. No Prior Vaccinations (within 4 weeks). Concomitant medications included ongoing lisinopril (Has been taking for years). It was reported that she was still dealing with migraines and everything else, and light sensitivity. Migraines started the day after the second dose on 16Apr2021, and she had it for 6 days straight. It settled some, enough for her to think straight. It was back again yesterday and was full fledge today. Has had to wear sunglasses ever since. Treatment: Imitrex and some Toradol. She had higher blood pressure in the beginning when she got the first shot in 2021. They gave her another blood pressure medication, stated that the blood pressure was better now. Sensitivity to light it was explained that this was lasting longer than the migraines; she was back in sunglasses due to this in 2021. She also has some sound sensitivity but that was part of the migraines. She has had this going on since the migraines started in Apr2021. Due to migraines patient visited Emergency Room the other month when this first started, in Apr2021. Was not admitted to the hospital. Was on 12 different medications in the previous year. Clarified that she was not on any other medications within 2 weeks prior to the Covid 19 vaccine. The outcome of event migraine was not recovered, blood pressure high was recovering, remaining events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Fully vaccinated for covid in January 2021. Cold symptoms on 7/12 started. Tested covid positive 7/16.
Chest tightness,  neck tightness, palpitations, shortness of breath, numbness.
Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to fainting, Shake, Chills, Loss of Appetite (didn't eat for 10 days), Fatigue.  Symptoms were intense for 2 days, then were mild for 2 days.
Received vaccine which expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Vaccine expired on 01-Apr-2022 and the vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursion.   The pharmacist reported that they thought that the vaccine will expire in June 2022 however the vaccine expired on 01-Apr-2022.   No treatment drugs were reported.
Pt given flu shot @ 1800. Experienced pain radiating from left armpit to neck/back, followed by lightheadedness, sweating and decrease in pulse from 68 to 59 BPM. Alert and conversing. Went to bathroom, felt better and returned and said she "didn't feel right."
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA274204, 2018SA274230 and 2018SA274229. This case involves a male patient (age not reported) who was vaccinated with a dose of  MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (it was reported that doses of vaccines stored outside the recommended range). It was reported that the patient had no side effects. 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 set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
LARGE REDDENED AREA OF 3X5 INCHES WAS NOTED WHEN I PICKED MY SON UP FROM SCHOOL ON FRIDAY. AREA WAS WARM TO THE TOUCH. BY SATURDAY THE AREA HAD GROWN LARGER AND MORE TENDER. CONTACTED HIS PHYSICIANS OFFICE AND WAS TOLD TO CONTTINUE TO MONITOR AND GIVE BENADRYL AND TYLENOL. BY TODAY, SUNDAY, IT IS STILL A LARGE RED AREA WITH HEAT AND STARTING TO BRUISE. THE INJECTION SITE IS VERY FAR BACK ON HIS ARM ALSO LEADING ME TO BELIEVE THAT THE INJECTION WAS NOT ADMINISTERED IM AS STATED ON FORM.
This spontaneous report was received from a female consumer of unknown age referring herself. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in late May or beginning June 2017 (reported as last week), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prophylaxis (dose, lot number and expiration date were not reported). Subsequently, the patient noted that the injection site bled more than expected (vaccination site haemorrhage) and stung (vaccination site stinging). Because of that, the patient thought the nurse might had administered the vaccine in her vein not subcutaneously. The patient stated that she did ask the nurse if she had administered the vaccine subcutaneously or if had been injected into the vein; however, she said that the nurse did not understand her. The patient did not seek medical attention, thus, she had not consulted her physician. Moreover, no treatment was given for the adverse events. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and the ZOSTAVAX was unknown. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender started to receive PREVNAR 13, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced experienced burning when vaccine was administered on an unspecified date with outcome of unknown. The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. No follow-up attempts are possible. No further information is expected.
Diagnosed with COVID-19 on 2/21/2021, 18 days after first vaccine injection, and 14 days after first symptoms - rapid test performed on 2/18/2021 came back negative
Tachycardia, lightheadedness, vasovagal response, flushing
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with MMR II. Dose, route, lot number and expiration date were not reported. The nurse reported that MMR II was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
arm pain, bone pain, back ache, GI upset, leg cramps, fatigue. sent to ER by PCP 3/17/21
Information has been received from a health professional concerning a female who in January 2008, was vaccinated with GARDASIL. Subsequently, the patient experienced a rash. The patient sought unspecified medical attention. Additional information has been requested. 07/08/08 Additional information received 19-MAR-2008: The nurse states, "I don't remember the students name. If she comes in again I will fill out the (B) form". Additional information is not expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
heart palpitations, tired, shortness of breath. 2 or 3 episodes.
PT presented with chest discomfort, coughing, and generalized weakness; Pt is on aspirin, lovonox; pancoprazole; carvedilol; Inpatient
I noticed the ringing in my ears when I laid down to sleep, then I realized that I had been "hearing" it for a while. It has been constant since then. Sometimes it is louder than others, but my ears are  ALWAYS buzzing/ringing... It is interfering with sleep, it is causing me frustrations and making me GROUCHY! I did not know this was a side effect until I broke down crying in frustration the other day and the gal that was with me asked if I had the vaccine... I then did research and found it is a side effect and wanted to report it, as everything I am reading only reports the results from the trials... how many people are dealing with this really? Will it ever go away? T thinking of having this the rest of my life is a very upsetting thought.
1st 24 hours-slight fever, itching, headache. Thereafter-red inflammed area at shot location x 48 hours.
Intermittent, random, and sometimes intense itching and/or burning in alternating locations: palms, backs of hands, back of neck, armpits, back of head, wrists, forearms, groin, shins, top of pinkie toes. No rash. Some mild blushing in palms during itching/burning. Itching/burning in each location lasts 15-60 minutes. Relieved with cold packs and epsom baths. Worse in the evening.
A 13 year old patient received 1st dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 13 year old patient received 1st dose of moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the concomitant medication ware not provided the treatment medication s was not provided
This spontaneous case reported by a consumer, describes the occurrence of blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient experienced blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash). Patient treated with Rituxan (rituximab) ongoing since an unknown date for blistering, at a dose of 1 dosage form. At the time of the report, blister (blistering/blistering disease), pruritus (itching) and rash (rash/terrible rash) outcome: unknown. No  concomitant medications or lab data reported. Most recent follow-up information incorporated: On Jun 30, 2021: Non-significant follow-up appended.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot#, expiration date, dose and route were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Acute urticarial rash 3x6 inches over anterior thigh. Site of DTaP. BENADRYL given.
I started feeling very sick. I went to the store and when I was heading back out to my car it felt as though the back of my body had cement poured over me and felt so heavy and I was very stiff. I began having fevers and chills that evening. I was very miserable and very hard to move my body. I needed help from family to get medication and help me with my daily activities including drinking water and being able to move. I had this go on for about 36 hours. I had fevers on and off since having vaccine. On March 11th I visited the ER bc I began having heart palpitations and they continued for long enough it concerned me. They feel it was because of my thyroid. I was monitored for a few hours. Blood work was done and they did find I was very dehydrated and that is strange bc I drink water all day through the day and track it. Once I received fluids the palpitations stopped. I am unsure if this part was related to the vaccine at all.
Pt experienced itching on first day, then also hives and numbness in fingers starting the next day.
Case previously recorded as MA2009-3779. Initial case report received from a physician via MedCom, on 04 NOV 2009. A 3 year-old male patient was inadvertently vaccinated with 0.5 mL of S-OIV FLUVIRIN 2009/2010 (batch no. 1008136P) i.m on 04 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007589.
Myalgia, Arthralgia, Injection site pain, Shoulder pain on right side Narrative:
30 minutes after injection, I began to have sciatic pain in left buttock. It progressively became worse throughout the day. Took pain pills I had on hand & went to bed. Woke up around 0200 in excruciating pain & took 2 more pain pills. When I woke up the following morning I was pain free & it never returned.
Patient broke out in hives after receiving SHINGRIX. She said on 1/6/19 she began breaking out, and went to the ER today 1/7/19. The emergency room doctor told her he feels she had an allergic reaction to the vaccine. The patient stated she also broke out in hives after the first dose of SHINGRIX, but had just started another inhalant and her doctor felt it was the other medicine, not the SHINGRIX. After receiving the second dose of SHINGRIX, she once again broke out in hives and the ER doctor told her he feels it is an allergic reaction to the SHINGRIX. She was given ZANTAC (which she already is taking) and a prescription for prednisone. I spoke with her this evening again and she says she is feeling better after starting the prednisone.