chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began reporting right upper arm achiness, redness and swelling last night the she had a difficult time sleeping 7/6/2016 because of the pain.  Around approximately 100PM Central time on 7/7/2016 patient was in front of her mother and friend and suddenly reported feeling nauseated after eating some blueberries and then became dizzy and fell backwards hitting her head and appeared to of been convulsing at home with her eyes rolled back in her head.  Patient's mother and friend were present during this syncopal episode.  Patient's mother immediately went to her father, who is a paramedic, who then laid her flat and was unsure if she was breathing as she was lying on her side.  After a couple minutes the patient was able to sit up and was alert and oriented.  At the time of speaking with the mother over the phone around 130 pm she reported patient was sitting in the recliner with ice on her right upper arm, eating something but still reported her legs feeling shaky.  At the time of this interview patient had not been seen or taken into a healthcare provider for further assessment and treatment after falling and hitting her head.   Vaccinations were received on 7/6/2016 in the afternoon, patient was observed for 15 minutes prior to leaving with no side or adverse effects after receiving vaccinations.
Eight days after vaccine, patient woke up with painful arm, difficult to move.  She reports large bump at injection site, and larger area of erythema surrounding it.  Our clinic has not seen patient in person, she reported this over the phone to us.
Pt had the 1st 2 vaccines in a series of 3, in April and May of 1998. She was hospitalized in July of that year because of her ankles and wrists were very swollen and she could not walk. She was also exhausted. They put her through a gamma of tests and came up with migratory arthritis. She suffers off and on with fatigue and joint pain since then. It flares up from time to time. She is always quite fatigued and has constant low-grade pain. The 1st onset with swelling and joint pain lasted at least 4 months, then down to a minimum. Flares up. Needs to sleep a lot and return from work early because of pain and swelling. She was hospitalized from 7/11/99 to 7/13/99. 8/3/99, returned for a check-up and report on all other tests were nml. Dx'd with probable viral arthritis but to us they called it Migratory Arthritis. They seemed to be a little baffled and simply choose to call it Migratory Arthritis. They said it would go away in time. In time it did settle down, but pt still lives with a certain degree of pain most of the time and she has flare ups of swelling and stiffness, causing her to leave school and work at times. None of these symptoms occurred before she had the Lyme vaccination.
An 18 year-old male patient had received an intramuscular booster dose of MENACTRA vaccine (lot number: U4594AB and site of administration was not reported) on 21-JUNE-2013. This the patient received an extra dose of MENACTRA. The patient had no known allergies to drugs and had no illness at time of vaccination. Concomitant medications were not reported. On an unspecified date 5 to 6 days after vaccination, the patient experienced headaches. The patient was seen on 01-JULY-2013. Laboratory investigations and corrective treatments were not reported. On 03-JULY-2013, the patient had recovered from event. Documents held by sender: none.
pressure on the arm (left); Herpes ampoules on back; Rash on right arm; pain on left arm; started to feel pain on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ). Concomitant products included INSULIN, METFORMIN, ATORVASTATIN and PIOGLITAZONE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain on left arm). At the time of the report, VACCINATION SITE PAIN (pain on left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
had my first Moderna vaccine on 3/21/21 and did not get my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first Moderna vaccine on 3/21/21 and did not get my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my first Moderna vaccine on 3/21/21 and did not get my second dose).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
On the morning after this injection (Friday), I began to experience pain in my left ear and neck. The pain increased over the weekend until the lymph nodes in my neck were palpable and my ear was painful to touch and felt swollen. On Monday morning (Sept 13, 2021) I went to the Urgent care to be seen. The healthcare provider confirmed that my ear was swollen nearly shut but that she did not see any signs of an infection. She also palpated the lymph nodes in my neck. I was advised to wait a few days and monitor. After 3 days, the swelling went down in my neck and ear.   Immediately after this vaccine (the afternoon and evening of 9/9/2021) I also had several hours of visible back spasms. My husband could see my back twitching from across our bedroom.  I also had facial (eye) twitching that lasted on and off for a week.   Roughly two weeks after this injection, I developed a large cyst in my left wrist. I've never had such a thing before.   Lastly, my TSH levels increased to unprecedented levels. My TSH levels have been within normal levels for several years. The most recent lab draw prior to this vaccine was drawn on 8/18/2021. My TSH was 0.57ulU/mL. The next lab draw done done at the end of October showed an increase of TSH levels to 22ulU/mL. That's not an error. TWENTY TWO.  I have never, ever had a TSH level so high before. There have been no changes in my health otherwise (no illnesses, no change in mediation) that could have caused this dramatic change.
No adverse event; HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP reported, the vaccinator gave a 4 yr with no prior covid vaccination Moderna 10 mcg from the pink cap instead of 25 from the blue cap).    No concomitant medications were reported.  No treatment medications were reported.
Right arm-sever pain at injection site, swelling, redness, limited mobility. Body aches, high-grade fever 103.3, vomiting, nausea, fatigue, Decreased appetite, abdominal cramping, low back pain
Patient given monovalent booster which is no longer valid and need to come back after 2 months for the bivalent booster.
Cold hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL COLDNESS. On 04-Mar-2021, PERIPHERAL COLDNESS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-072679. Sender's Comments MOD-2021-072679: Second dose of vaccine case.
I have had a heart flutter since receiving the vaccine.   It sometimes takes my breath away.  It is flutter feeling which almost feels like my heart is skipping a beat.  Have never experienced anything like this before.
Anaphylaxis. 2 minutes after injection I developed tingling of lips and tongue. 5 minutes after I couldn't speak well and developed a cough. 10 minutes after ER doc gave me pepcid 20mg and zyrtec 10mg. Cough and shortness of breath started and tongue swelling. I was then taken back to an area with team including ER doc and 2 nurses. Given benadryl liquid and ultimately epi injection. Called Ambulance and taken to Hospital where I was given more benadryl IVP, ativan, and monitoried for 8 hours. Pruritic, congestion, and difficulty talking since day of shot. this is day 2 after injection
Information has been received from a female consumer who on 30-JAN-2007 was vaccinated with the first dose of Gardasil (0.5 ml). Subsequently the patient stated that as of 31-MAY-2007, she had not gotten her periods. At the time of this report, the patient had not received the second and third doses of the vaccine. The patient did not have a physician at the time of this report. No further information is available.
Flushing. A company representative reported that a child received Prevnar and within 1 hr of vaccine administration, developed flushing of the neck and back. No further information was available at the date of this report. This is on of two pt's from this facility who experienced an event following receipt of Prevnar.
Allergies got more severe pretty immediately after my second shot. But the number one thing I have concern about is I haven?t gotten my period since my second dose. I have an IUD which makes my periods regular, but I have not had by period since 4/7, so it is late by two full weeks now and it has not returned yet.
cough; Maybe he had a coronavirus cold at some point; Terrible headache/headache; Feels like he has a cold much of the time; Chest tightness; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough), SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) and HEADACHE (Terrible headache/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 042l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN from 01-Jan-2018 to an unknown date for Heart disease, unspecified, VITAMIN D [VITAMIN D NOS] from 01-Jan-2019 to an unknown date and PROBIOTICS NOS from 01-Jan-2017 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness) and HEADACHE (Terrible headache/headache). On an unknown date, the patient experienced COUGH (cough) and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point). On 27-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough) and HEADACHE (Terrible headache/headache) had not resolved and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: 110/66 (normal) 110/66 mmHg. On 21-May-2021, Body temperature: 96.6 (normal) 96.6 F. On 21-May-2021, Heart rate: 64 (normal) 64 beats per minute. On 21-May-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up appended. Concomitant medications added, new events was updated, outcome was updated.
I have broken out in a rash or kind of hives that has moved through different parts of my body. The rash has little bumps and red when irritated. I have taken benadryl and it seemed to be getting better. When the medicine wears off it start again. The rash mostly is all over my legs. It's been 3 days and is still going, but appears to be somewhat less now.
Developed itching 10/9 & hives 10/10 - used OTC BENADRYL at home which helped, was seen by outside urgent care in her area was given steroids and advised to avoid Flu shots - has hx of food/animal allergies - was out with animals 10/9.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, 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.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.    This case was linked to MOD-2021-364740 (Patient Link).
Information has been received from a consumer concerning her 18 year old granddaughter, who, on an unspecified date, was vaccinated with a dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient was pregnant when vaccinated. The patient did not seek medical attention and did not received prenatal care. It was reported that bloodwork was performed. On 06-APR-2008 the baby was born prematurely at approximately 36 weeks and was diagnosed with a terminal illness Trisomy 18. At the time of the report the outcome of the patient was unknown. No product quality complaint was involved. Additional information is not available.
it is kind of warm as if the arm has a fever/yesterday it started feeling like I had a fever kind of; at the site of the injection, it was kind of itchy; it was very sore and swollen/large about the size of a peach; There is a huge bump at the side of the vaccine; it was sore/it was very sore and swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in arm on 25Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate (FLOVENT) taken for asthma. In Apr2021, at the site of the injection, it was kind of itchy and she wanted to scratch it and it was very sore and swollen. So, she just had large about the size of a peach or something. There was a huge bump at the side of the vaccine and it is kind of warm as if the arm had a fever and it was sore. She mean it was sore the following day (26Mar2021). But then she didn't really notice anything until maybe yesterday or the day before (Apr2021). It started out just feeling kind of itchy but when she went to scratch it, it felt like a big notch and it was a sore and then yesterday (02Apr2021) it started feeling like she had a fever kind of. She didn't have a fever. No treatment received. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
11:05/Vaccine administered, 1120 patient became pale, diaphoretic, fell back in her chair. According to Patient's mum, Pt lost consciousness 15 minutes after receiving vaccine. One unit lead notified and witnessed Pt sitting in her chair alert and in distress. Medical lead and an EMT on the bus arrived to the scene. Upon assessment, Pt. AOX4, cyanotic and pale looking. Pt placed on the floor, supine position, 911 called. V/S checked, BP 101/51, HR 44, O2 80%, RR 16. Pt able to followed commands and answer questions. Pt remained calm, reassessed after 5-minute, V/S: BP 104/60 HR 66, O2 90%, RR. 16, still cyanotic. EMS Personnel onsite arrived. Care transferred. Pt transported to the ER via ambulance.
Administered Tdap and varicella in client's right deltoid.  Client stated that he felt dizzy and appeared pale.  I asked if he felt like he was going to be sick he said yes.  I placed the trash can in front of him and he started vomiting within a minute.  He vomited 3 times and remained pale and dizzy.  He remained seated with a cold compress on his forehead.  BP was 90/62, lungs clear and denied difficulty breathing.  Client stayed 15 minutes after vomiting and said he felt better.  Instructed to call if any other s/s.  Was not given MCV4 as planned.  Will return with mother for future imms.
Information has been received from a registered nurse concerning her 14 her old daughter with mild asthma, who on 18-JAN-1997 and on 02-NOV-2007 was vaccinated with first dose (dose, route and lot number provided) and second dose (dose and route not provided lot number 658407/1176U) respectively of VARIVAX (Merck). The nurse reported that her daughter developed chickenpox after first vaccination and subsequently when after receiving the second dose she was experiencing chickenpox that began about two days ago (on approximately 31-MAR-2009). The second case is very mild and she had blisters on her legs and one blister in her mouth. She had been prescribed acyclovir. At the time of reporting patient had not recovered from the event. The patient was seen at the office. Additional information has been requested.
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013268: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
patient reported adverse pain from flu shot received 01/18/202 on 01/25/2020 patient believed there were issues with safety and sterileness of injection. patient stated had went to see md from pain in upper arm and shoulder radiating from injection site since time of shot that would not go away. md believed issue was in injection site and gave pt medication for issue, from image shown puncture if truly from shot higher than deltoid area. pt also beieved issue with injecting pharmacist opening needed then leaving
Took 2nd Shingritz injection on 11/20/20. Two days later had MAJOR outbreak of HSV2, after several years symptom/outbreak free. (Had ceased having outbreaks after Zostervac vaccine.) This is worst outbreak since initial one more than 40 years ago. Anecdotally, it appears that many others have had this occur. Thought you would want to know.
Vaccine at 8:45 AM. By 11 AM was feeling ill. Felt "woosy". Whenever she stood up she felt out of control of her body, dizzy, nauseated. Kind of an intoxicated feeling. Temp up to 102.5 with Tylenol. Generalized hot flashes. Went to bed at 7:30 PM because she felt so bad. Went to sleep and slept all night. Woke up feeling normal except her arm which was swollen and sore and red  (quarter size area at injection site). Arm remained sore for one week.
This spontaneous report as received from a nurse refers to 3 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, between 28-NOV-2016 and 19-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M022400, expiration date 01-NOV-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 8.2 degrees Fahrenheit for 30 minutes. Data logger was involved. Previous excursion of 7.7 degrees Fahrenheit for 1 hour 30 minutes was also reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored, oral, ROTATEQ (Lot number, expiry date and dose were not reported) oral. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.