chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a heart attack; I had a blood clot in my lung; stabbing pain in chest; This is a spontaneous report from a contactable consumer.   A 76 years old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. About 30 hours after 1st dose of vaccine the patient experienced stabbing pain in chest wall, quite persistent. At first she thought was having an heart attack. Hurt too much to move. Had to lay down. Thought she had a blood clot in her lung severe for 2 days, moderate for 2 day.  It was dissipated after 6 days. The patient was scheduled for second dose on 20Feb2021. The patient recovered from the events on an unspecified date.   Information about Batch/Lot number has been requested.
Treatment of COVID-19; Treatment of COVID-19; Dose 3: Moderna/Dose 1, 2, 4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 at 15:45 as dose 1, single (Lot number: ER2613) and on 21Apr2021 at 10:45 as dose 2, single (Lot number: EW0171) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 013FZIA) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "overweight/obese" (unspecified if ongoing), notes: other medical history: overweight/obese. The patient's concomitant medications were not reported. The patient has no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021 at 15:00, outcome "unknown", described as "Dose 3: Moderna/Dose 1, 2, 4: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2023) Positive; (21Mar2023) Positive; (28Mar2023) Negative; (30Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After my second dose I had bleeding of my gums for about a week.  There was a lot of blood when I would brush my teeth.  After the second dose I started getting intermittent numbness along the sides of both hands from my wrist to the end of my pinky fingers.  I haven't had it happen for a few weeks.  Also in that same area of my hand it sometimes is very sensitive and feels like I have a burn.
10/26/18 in the evening 9:30pm injection site started swelling, couldnt sleep from pain/swelling.  On 10/27/18 noticed a welt at the injection site and other areas of the arm, itching, warm to the touch, swelling. Headaches, nausea, chills, no reported fever, lack of appetite. has been applying BENADRYL cream, started taking TYLENOL on 10/26/18, didnt help switched to ALEVE on 10/27/18 helped temporarily.
1st dose on Dec2021, 2nd dose after 10 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on December 2021).   On 14th October 2022, the patient received the 2nd dose of Shingles vaccine. On 14th October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient went last Friday and received 2nd dose of Shingles vaccine. The patient stated that the girl who gave him/her dose and said that it was okay that he/she waited for 10 months between the 1st and 2nd dose. The reporter reported he/she now saw on GlaxoSmithKline website that should have Gotten. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Tested Positive for Covid on 5/6/2022. Paxlovid was prescribed and tested negative on 5/11/2022. Tested positive again on 5/18/2022 with first symptoms /17/2022. Symptoms minor both times
Left arm started twitching today at the injection site; Left calf started to spasm regularly and started to have periodic muscle cramping in the left foot; Left calf started to spasm regularly and started to have periodic muscle cramping in the left foot; Periodic headaches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously took acetylsalicylic acid (ASPIRINE) on unknown date for an unspecified indication and experienced drug allergy. On an unknown date in May2021, about 4 months after the 2nd dose the patient experienced left calf started to spasm regularly and he started to have periodic muscle cramping in the left foot along with periodic headaches. On an unknown date in Jul2021, now 2 months later, his left arm started twitching today at the injection site. The events resulted in emergency room/department visit or urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left calf started to spasm regularly and he started to have periodic muscle cramping in the left foot along with periodic headaches, started twitching today at the injection site were not resolved at the time of reporting.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Lymph nodes enlarged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Lymph nodes enlarged) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes enlarged). At the time of the report, LYMPHADENOPATHY (Lymph nodes enlarged) outcome was unknown.            No concomitant medication information was provided. No treatment products information was provided. Patient received her second dose of the vaccine to the left arm on 13 MAR 2021.  4-5 days after receiving this vaccine she noticed the lymph nodes near her left collar bone were more pronounced. She noticed this while she was rubbing some lotion on her neck. The lymph nodes were not tender or swollen, just more pronounced. She had not taken any treatments for her lymph nodes. She had talked to her doctor and pharmacist who both said this was an expected reaction. action taken for Moderna COVID-19 Vaccine was not applicable.
Pt. reported feeling lightheaded and about to Faint at 1:18. I arrived at the seen at 1:19, where she had a  seizure for about a min. Vitals were taken, 911 called at 1:20 911 was called and Pt. refused or signed AMA
My joints were extremely sore and I was very cold.  Problem not nearly as bad on 1/23/2021.
As the shot was going into the arm, the liquid entering the muscle nearly immediately felt like it was fire. The patient was unaware of what is considered "normal" with the shot and thus said nothing to the pharmacist. Over the next 15 min, the arm started to swell slightly and was extremely sore. Soreness and swelling were expected because these symptoms had happened after dose 1. Within an hour after the dose, the patient had a rash that went across the entire face (the face looked sunburned). Over the next five days, the patient's arm continued to swell and produce heat. Heat and swelling were evident until 4/11/2021, however the worst of these symptoms occurs within the first 3 days after the vaccine. A rash was evident from the upper arm, where the injection occurred, up the back and onto the neck and face. The facial rash is still present today, although not as prominent as it was in the past.
Employee came to   for 2nd COVID19 vaccine dose.  The MA drew up a full vial that was not diluted. Therefore, the employee received more vaccine than he should have.  Once discovered, the employee was contacted by the  Medical Director, was told about the incident and what to expect, and was instructed to call   or the medical director with any concerns.  Pharmacy were notified. administrative oversight for  were also notified. The vaccine vial had been sitting in an opaque bag on the counter as it needed to be at room temperature for 15 minutes before reconstitution. The vial (lot number EW0179) was intact and no expiration sticker was on it.  Since this event, the clinic has changed practice of drawing up each dose as needed and will draw up all 6 doses from a vial, label/date them, and place in an opaque bag ready for use.  The syringes will be good for 6 hours as verified with pharmacy.  The  clinic administers many vaccines, all of which are unit dose.  Drawing up all syringes from a COVID19 vial will more closely align with this practice.
Warm, erythematous rash at injection site and  less-so over right deltoid as well
Itchy skin; Red rash; Painful rash; Rash which migrated to top of his biceps and side of the injection site; very intense at the injection site/near rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very intense at the injection site/near rash), PRURITUS (Itchy skin), RASH ERYTHEMATOUS (Red rash), RASH (Painful rash) and RASH (Rash which migrated to top of his biceps and side of the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE REACTION (very intense at the injection site/near rash). On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH (Painful rash) and RASH (Rash which migrated to top of his biceps and side of the injection site). On an unknown date, the patient experienced PRURITUS (Itchy skin). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (very intense at the injection site/near rash), PRURITUS (Itchy skin), RASH ERYTHEMATOUS (Red rash), RASH (Painful rash) and RASH (Rash which migrated to top of his biceps and side of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-163283, MOD-2021-163283   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up  received on 25 May 2021 and updated reporter information and event. On 23-Jul-2021: follow up received , email address was added.
Pt c/o mild pain at left upper arm at previous injection site with redness and tenderness (2" x 5" of size). Pt stated scratching area after 4 days of injection.
It was one of the tetanus vaccines. About 2-3 hours after injection, he began to have a seizure. At that time, we also noticed a rash/swelling was on his leg surrounding injection site. The rash spread to both legs & up his abdomen. He continued to seize every few hours or so. When we took him back in, they informed us that they would not do anything until he had been seizing for 15+ min. He also spiked a fever of 103 that would only go down while on MOTRIN/TYLENOL alternating per Dr recommendation. We noticed on Thursday that there was a hard bump under the injection site. He continued to have seizures for several days. The fever finally stopped on Sunday, the 9th. The seizures stopped on Monday the 10th. The rash & swelling also started clearing on the 10th.
Asymptomatic other than short-lived nausea lasting 1 hour; Abnormally elevated LFTs done 48 hours after vaccination
PATIENT RECEIVED  DOSE AT 11:30AM, AND FELT OK.  WAS APPREHENSIVE BEFORE RECEIVING AND ADMITTED BEING FEARFUL YESTERDAY.  SHE WALKED TO THE FRONT OF THE STORE AND ALERTED MY TECH THAT SHE WAS NOT FEELING WELL. PATIENT WAS SHAKY AND SWEATING, AND GENERALLY FEELING UNWELL.  SHE FELT 'FAINT' AND WE HELPED HER TO A CHAIR.  A BYSTANDER, NURSING AIDE, ASSISTED IN CALMING PATIENT.  APPROX 11:40 PATIENT FELT SOME CHEST PAIN AND WE HAD ACTIVATED EMS TO EVALUATE.  RESPONSE WAS APPROX 11:46 AND SHE WAS ASSESSED.  PARAMEDIC SUGGESTED PATIENT BE CHECKED UP TO THE LOCAL EMERGENCY DEPARTMENT.  TRANSPORTED APPROX 11:52.
pt had a tingling tongue about 30 minutes following the vaccination. pt mom said her lips looked a little swollen. Pt blood pressure  was taken and was 119/77 and HR of 76 BPM. She took oral benadryl 10 ml = 25 mg once in the pharmacy, and symptoms resolved after 15 minutes.
Tinnitus began four days after shot was administered; is still ongoing although not as bad as it was at first. Having mood disturbances and general lethargy as well.
Fever 102 degrees with erythema, pain induration lateral aspect of upper portion (L) arm.
Patient passed 36 days without 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 PRODUCT DOSE OMISSION ISSUE (Patient passed 36 days without second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient passed 36 days without second dose). On 26-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient passed 36 days without second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Case number PHEH2013US019878, is an initial spontaneous report received from a pharmacist on 19 SEP 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 SEP 2013. No adverse event was reported following this administration error.
I was 14 weeks pregnant when I received the first dose of the moderna vaccine, on Feb 8, 2021. On February 16 I went for a routine checkup to my OBGYN and the baby was found without a heartbeat. The baby was measured to be 13 weeks 5 days or 13 weeks 6 days, however these are just estimates and are not necessarily exact. I have a history of carrying smaller babies, so it is possible that the baby's gestational age was greater than 13 weeks 5 or 6 days. My original estimated date of delivery was August 9, 2021.
On 09/13/2022 the patient received a dose of MODERNA -COVID vaccine LOT # 055A22A as  the 1st dose of the primary series. Patient guardian then presented a document from patient's country stating he had received PFIZER COVID vaccines as follow: 1 st dose on 09/23/2021 LOT # 31130BA. 2nd dose- 10/15/2021 LOT # 31076(number 8 or letter B) D., and PFIZER Booster on 02/21/2022.
Devel rash & the next day swelling & tenderness, joint areas; DPH & Advil recvd;
Pt reported feeling achy and feverish 3-4 hours after vaccination and had a low grade fever that continued for approximately 24 hrs.
pt recv vax 15MAR96 & stated last Td 9-10yrs ago no prev rxn;pt began having warm,swollen arm @ inj site rt deltoid;warmth & swelling progressed down arm to forearm on 16MAR & 17MAR;c/o chills & felt cold;noticed red streaks on rt arm
Fever, chills, muscle cramps (muscles locked up momentarily), nausea.  Flu-like symptoms, felt very bad and had to miss work for 1 day. Felt much better after 24 hours from the time of the shot.
At approximately 1415, patient reported minor swelling/numbness traveling from her left arm up to the left side of her face. Patient advised to wait for further observation. At approximately 1430, patient reassessed. Patient had no difficulty breathing. Lead nurse educated patient educated on signing up with V-Safe, seeking emergency care for any difficulty swallowing/breathing, and following up with primary care provider about her reactions to the vaccine.
Information has been received from a health professional concerning a 7 year old female child, with no known drug allergies, who on 17-APR-2008, at 4:42 pm, was vaccinated with the second dose, SC in the left thigh, of  VARIVAX (Oka/Merck) (lot # 660080/1975U). There was no illness at the time of vaccination. On 17-APR-2008, at 11:45 am, the patient developed a red and swollen left lateral thigh (3.25 x 1.5 in central induration with overall 7.5 x 4.5 in. redness). Treatment included cetirizine (manufacturer not specified), 1.5 tsp at bedtime. On 22-APR-2008, the child recovered from the symptoms. Additional information is not expected.
Starting 1 hour after 1st dose of the vaccine, I started to notice a rash on both my arms and going up to my neck. It was red and bumpy.  Over the next several hours it spread all over my body from head to toe.  I took Benadryl and it did not help.  I started to get very itchy all over.  No fever.  On certain areas were very red and bumpy especially legs and stomach.  On 4/2/2021 (2 days after vaccine), I contacted my doctor.  She recommended to continue Benadryl and cool bath, which helped a little.   The rash lasted for several days. It eventually went away.  The itchiness went away first. By day 6-7 the rash completely resolved.
After injection patient felt severe arm pain. Thought it was normal but in Continued for a week after. Pain was described as a very deep pain in the muscle that was warm to touch & slight swelling. Patient did say she felt shot was given high up on the arm and took a while to go in. Pt continued to have pain a week after where she then went to her primary doctor who wanted to do an X-Ray. Results are Pending at the time of this Report.
Child had received Hep A shot (R) thigh. Developed weakness within 15 minutes. No SOB, no wheezing, clammy. Vitals stable but was lethargic.
patient started having left  shoulder pain and back pain 7 days after receiving injection. No numbing, tingling, or skin coclor change. Told patient to take Tylenol and seek medical care.
Vesicles, erythema, widespread. Dx: chicken pox post vaccination. Tx: Acyclovir, Bactroban cream.
Vial was punctured about 24 hours before vaccinated (beyond 6 hours of recommended time). Syringe was drawn and kept in the refrigerator the entire time. Patient hasn't developed any adverse effects. Moderna company was informed and discussed about the next step.
tested positive for covid on     10-1-22  had cough                       , deceased on    12-7-22                        .  Given paxlovid at residential facility
severe vertigo / diagnosed with benign vertigo syndrome; not feeling well; fatigue; did not have an appetite; nauseous; dose 1 of Shingrix in October 2020 / dose 2 on November 12, 2020; Epstein Barr syndrome; sore arm; This case was reported by a consumer and described the occurrence of vertigo in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th November 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. In November 2020, the patient experienced vertigo (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), fatigue (serious criteria hospitalization), appetite lost (serious criteria hospitalization), nausea (serious criteria hospitalization) and epstein-barr virus infection. On an unknown date, the outcome of the vertigo, feeling unwell and fatigue were not recovered/not resolved and the outcome of the appetite lost, epstein-barr virus infection and drug dose administration interval too short were unknown and the outcome of the nausea and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo, feeling unwell, fatigue, appetite lost, nausea, pain in arm and epstein-barr virus infection to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. In October 2020,the patient received 1st dose of Shingrix concomitantly. The patient received the 2nd dose of Shingrix on unknown arm and 1 hour after the vaccination patient experienced sore arm.. Approximately 1 week after the vaccination, the patient felt unwell, did not have an appetite, fatigue and nauseous. The patient took a nap and when he woke up noted severe vertigo. The patient was called the paramedics and was taken to the emergency department later he was being evaluated for a possible stroke. The patient was later diagnosed with benign vertigo syndrome. The patient did not feel well so insisted the doctor to check for a viral infection. The patient received the 2nd dose of Shingrix before recommended time interval, which led to shortening of the vaccination schedule. The lab tests were performed such as MRI (Magnetic resonance imaging) and CT scan (Computerised tomogram) which was normal;also blood work done and the report received on 20th April 2021 which states the patient had Epstein Barr syndrome. The reporter consented to follow up. This case was linked with US2021089133 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089133:same reporter
Body was extremely hot and red,  and I also had chills.  Arm was very hot and sore and swollen.  Entire body ached (like I have never had before) , nausated, bad headache, very weak.  My urine was a different color (kinda of peach/pink).  I took Tylenol to help with fever etc., for a couple of days.  I still fatigued from the ordeal.
NO REPORTED AE, HOWEVER, VACCINE WAS ADMINISTERED IM INSTEAD OF SQ, PER BAVARIAN NORDIC NO REPEAT DOSE IS REQUIRED