chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two other friends said that taking the vaccine was like having the disease; pain in the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm). At the time of the report, VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614664 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614664:Master case (Friend with eczema)
Woke in morning on 1/14/21 with burning/throbbing pain in right great toe. As the day went on, I felt like I had ice blocks on both feet although right more than left.  As the days went on I started feeling loss of warm/hot sensation to both feet, tingling/burning and coldness sensation through both feet and halfway up calves.  I could not get my feet or lower legs warm.  Eventually I began feeling this same coldness and tingling sensation in both hands/forearms along with extreme coldness to both hands.  As of today, I do have more sensation back to both feet although the right big toe still throbs at times.  The tingling sensation is minimal in bilateral hands and wrists at this time.
Narrative:  Patient hospitalized 7/31/21 after completion of COVID-19 vaccination series in Feb 2021. Did not need steroids or oxygen for COVID but did develop bacterial pneumonia and leukopenia which was treated during stay. Discharged to rehab facility 8/10/21.
70 y.o. male with a history of CAD, CABG, HFrEF, HTN, DM2 who presented yesterday with 3 day history of fatigue, SOB, cough, and precordial CP. He was hypoxic, started on supplemental 02, tested COVID (+) and started on dexamethasone and remdesivir. Cardiac enzymes elevated 0.5 up to 2.79. He has noted chronic exertional angina for the past several months and maybe up to the past year. He has had multiple COVID exposures with family. He denies any fever, N/V/D, no loss of taste or smell. No HA. He does note some lower rib pain with cough.
Around 6:00 pm I started getting body aches, chills and a low grade fever. I had difficulty sleeping and according to my fitness tracker my resting heart rate went from 55 bpm to 65 bpm. The injection site is extremely sore (can?t sleep on it). The day following the vaccines I also experienced a low grade fever as well, but not the muscle aching. Day 3 following the vaccine my arm is still very sore, and my sleep is still disrupted.
This spontaneous report was received from a medical assistant and refers to a 69 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 28-JAN-2019, the patient was vaccinated with a pediatric dose of VAQTA lot # R010369, expiration date: 25-MAR-2019 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. No adverse effects were reported.
About 2 or 3 hours after receiving vaccine, pt noticed a nickel-sized bump on left cheek. No other signs, it's not bothering pt at all. Not sure if related to vaccine.
pt recv vax AUG96 & staring & swallowing, sz & vomiting off & on all day;noc of 21AUG96 pt went limp, eyes set to side & body started jerking w/some frothing @ mouth (no fever);911 called;jerking sz;t102;stopped breathing, turned blue
Arm pain and arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain and arm soreness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain and arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm pain and arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-103358 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-Jun-2021 and does not contain any new information.
The patient had a stem cell transplant in 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced stem cell transplant (Verbatim: The patient had a stem cell transplant in 2023). The outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix and Shingrix.     It was unknown if the company considered the stem cell transplant to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2023 and 16-Oct-2023 The reporter reported that patient received Zostavax in 2020 and both doses of Shingrix vaccine in 2022. The patient had a stem cell transplant in 2023 the reason was unknown for stem cell transplant. No patient demographics known except the patient gender. The reporter consented to follow up.
Confirmed COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: Viral swab (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Vaccinated on 12/23/2020 at 1 PM. Moderate pain and tenderness on injection site. One white pustule on left tonsil. Tender lymph nodes. Moderate generalized body aches. Mild headache, mild fever. Went to urgent care Negative for mono and strep. Got script for erythromycin if symptoms persist.
On the morning after vaccines were administered, mom noted a red, tender area around the vaccine site. Patient c/o pain at site, and mom marked reddened area with pen. The next day, area was larger, more red and tender, and patient began to limp slightly on that leg. Patient was seen on the third day, and site "looked better" per mom, but was still red, tender and warm to touch.
Tingling face; Tingling arm injection arm; Nauseous; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Feb2021 15:00 (Lot number: EN9587) as dose 1, single and intramuscular, administered in arm left, administration date 04Mar2021 15:00 (Lot number: EN6199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "viral Asthma" (unspecified if ongoing), notes: viral. Family history included: "Latex" (unspecified if ongoing); "environmental" (unspecified if ongoing); "foods" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Zpack, reaction(s): "Allergies"; Prevacid, reaction(s): "Allergies". Vaccination history included: Flu block (Anatomical site of injection: Left arm, two weeks and two days prior to first doe), administration date: 23Feb2021, when the patient was 50 years old, for immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 11Mar2021 16:30, outcome "recovered" (25Mar2021), described as "Tingling face"; PARAESTHESIA (non-serious) with onset 11Mar2021, outcome "recovered" (11Mar2021), described as "Tingling arm injection arm"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nauseous"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "weakness". The events "tingling face" and "tingling arm injection arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia, paraesthesia.  Additional information included as almost immediately she was nauseous. They started monitoring me 30 minutes tingling right arm (elbow to solder), 45 minutes while arm kept moving to drank water , tingling's stopped at 60 minutes went to drive home from Apt. Face tingles started at 1 hr 30 min on right side of face started mid face ear to nose, spread to chin, forehead right eye, 5 days mild weakness at mouth bottom lip and right cheek by eye. Resolved at day 14, functions had returned to normal.  No follow-up attempts are possible. No further information is expected.
patient called triage line today to report "worst headache of her life" with visual/auditory changes.
Near Syncope, lymphadenopathy, decreased urine output, elevated D-Dimer
Moderna; Pfizer Bivalent; Suffered ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (ongoing); "heart bypass", start date: Nov2012, stop date: Nov2012. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical Location: Arm, Lot: 013L20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical Location: Arm, Lot: 016M20A), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical Location: Arm, Lot: 002F21A), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical Location: Arm Lot: FP4554), for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. The following information was reported: ISCHAEMIC STROKE (hospitalization, disability, medically significant) with onset 03Jan2023 at 10:00, outcome "recovering", described as "Suffered ischemic stroke"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, disability, medically significant), outcome "unknown", described as "Moderna; Pfizer Bivalent". The patient was hospitalized for interchange of vaccine products, ischaemic stroke (hospitalization duration: 1 day(s)). The event "suffered ischemic stroke" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging and all results was not provided. Therapeutic measures were taken as a result of ischaemic stroke. AE treatment: CT scan, MRI, EKG, neurology visit, heart monitor.  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.
Not reporting an adverse event; patient had NO ADVERSE EVENT. I am reporting a vaccine administration error: Pfizer bivalent booster was given for first vaccine in primary series due to shortage of monovalent vaccine availability
red macular rash w/ pruritis after vaccine, increased fussing after vaccine. Red, swollen, tender ring @ vaccine site on (L) leg.
Initially after receiving the vaccine, I had skin sensitivity across my whole body. I had fatigue, and my arm was sore. My arm was also a little swollen and a little red. I took some acetaminophen. Those symptoms lasted for a day. When I caught covid, my first symptom was a sore throat. I had a runny nose, cough, congestion, tired, a headache, and I sneezed a lot. I had mucus and water coming out of my nose. I had no fever. I took some acetaminophen. Those symptoms lasted for about 2 weeks.
A report has been received from a Health Professional concerning a 28 year old, female subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 17-Nov-2014. The patient experienced pregnant patient got FLUMIST QUADRIVALENT which started on 17-Nov-2014. The outcome of the event of pregnant patient got FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Patient reported dizziness, nausea, vomiting, and chills. No report of difficulty breath or syncope. This started "a few hours" after administration and after patient had done strenuous activity. Patient referred to ED if primary care could not visit primary care immediately or if symptoms worsened. Verbally given list of early signs of anaphylaxis and also ADRs associated with Bexsero.
10 minutes after vaccine:  itching of arms, followed by back and chest, and into legs Rlevated BP 50 min-1 hr: itchy throat followed by paroxysmal cough
This spontaneous report was received from a licensed practical nurse regarding a 20-year-old patient of an unknown gender. Information on pertinent medical history and drug reactions/allergies were not reported. On 02-JAN-2019, the patient received PROQUAD (strength, dose, frequency were not reported) lot# R008205 with expiry date of 16-SEP-2019 for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstituted with diluent (DILUENT MRK INJ). No adverse effects were reported. No product quality complaint (PQC) was involved.
Extreme weakness, unable to stand or walk. Started to lessen after two days. Then, all joints started to ache. Now they are aching and swelling. Pain on scale of 1-10 is  6 and getting worse.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (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.
Information has been received from a physician concerning a female who was vaccinated on unspecified dates with all three doses of GARDASIL (lot#'s not reported). Subsequently the developed condyloma after completing the three dose series. The patient's outcome was not reported and she sought unspecified medical attention in the office on an unspecified date. Additional information has been requested.
Swollen Lymph Node-Right Supraclavicular.  Lethargic, loss of sleep and restlessness.
I received shot at 5:30 and itchy rash commenced about 10:00 that night and has increased since then and has spread all over my body (NOT the shot site), but on neck, in ear, chest,  torso. The rashes are streak-like.
I got the Vaccine at about 1:45 PM. About ten min later my heart started racing and it was getting harder to breathe. We called over someone in the waiting lot and they accessed me and gave me benadryl.  After another 5-10 min I couldn't get a good breathe, hard time swallowing, couch and itch in throat and got an epi-pen and transported to ER. I was put on steroids and beta blocker and stopped the reaction.  While in the ER my O2 went down to 92 but I was better than before.  I went home after hours of observation with prednisone and Beta blockers. I followed up with my Dr. When the 5 day steroid was stopped I almost immediately started struggling to breathe again and hard time swallowing. Dr. put me on a longer dose of prednisone. I'm starting to taper off the prednisone and my throat is hurting, itching and a little swell. I follow up again today.
This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the intramuscular formulation administered by other route and injection site erythema were unknown and the outcome of the influenza-like symptoms was recovered/resolved. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported one of her coworkers received the second dose of SHINGRIX subcutaneously, which lead to intramuscular formulation administered by other route. The reporter stated the patient subsequently had redness at the injection site and flu-like symptoms. The reporter stated the flu-like symptoms that resolved after 36 hours. When agent requested healthcare professional (HCP) full demographics, HCP provided the patient's contact information. When agent again requested HCP contact information as the reporter the chat was ended abruptly by the HCP. The reporter reported as physicain however in narrtive reporter was given as nurse, so reporter nurse was captured in the case.
I developed a rash that lasted for 4 months on my hands and face around and in my eyes. I was given perscription cream for my hands and eyes by my primary care Dr and the eye Dr. I also developed within 24 hours developed a ringing in my right ear that is still present 13 months later.
wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NOROVIRUS INFECTION (non-serious), outcome "unknown", described as "wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose".  Additional information: It was reported that no PQC was present. He received the 1st dose of the covid vaccine on 31Mar2021. He would like to know whether he can get his 2nd dose of the vaccine tomorrow. He says his pharmacist may have already reported it. He asked that further questions should be referred to his pharmacist. He and his wife, both aged 60, received their 1st dose of the covid vaccine on 31Mar2021. They both wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose. They were asked to wait a week before getting the next dose, but on the following week, the pharmacy had run out of the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 2021535377 Same Reporter/Drug/AE, different Patient
Patient came in on Monday, October 2, 2023 with a fairly significant bruise on his right arm where the injections were given.
This is a 4 1/2-month-old male infant vaccinated in a study who had hematochezia reported to the study PI on 11/3/2010 by study report card submission.  The patient had some reported blood in his stool 2 to 4 episodes per day, from 10/23/2010 to 10/27/2010. The mother had changed the patient's formula prior to that. The patient's primary Dr. changed the patient to prosoybee formula on 10/22/2010 a soy-based formula, and the blood in the stool stopped on 10/27/2010.  This appeared to be unrelated to vaccine dose #2 administered from 10/1/10.  This AE resolved completely by 10/27/10 and did not recur.  This AE appeared to be related to the formula change.  This serves as the initial and final report as there was no recurrence.
Employee reported itching to roof of her mouth and numbness to right side of her throat. She also had elevated HR of 113. She was taken to ED for further evaluation and treatment.
12/24/2019:30pm. Bath time, Left eye twitch. Limp a few seconds. Unresponsive a few seconds. Entire episode < 30 seconds. To ER for eval. 12/30/2019 PCP -fully resolved F/U PCP 12/30/2019 Patient is a 6 m.o. female who presents with mother and aunt for evaluation of possible seizure. Mother was giving a bath around 4:30 this afternoon. Child in an infant bathing seat with mother supporting her. Mother describes child twitching her left eye as if she might have gotten something in her eye, esp when she observed child to reach up and rubbed the eye. Child then abruptly seemed to become limp for a second or two. Mother picked her up and she seemed asleep. She then had a brief episode where her eyes seemed partly open and shaky. No whole body convulsions. Child seemed to become unresponsive again for a couple seconds and then snapped back to her normal self. Whole sequence of events lasted about 30sec. No recent fevers. Her oral intake has been somewhat limited over past couple days as she had taken about half the number of bottles as her usual. Took 3 today which was improved. No noted changed in urine or stool. She did not seem to be in pain. She did get her 6mo set of routine vaccines 5 days ago. Called her pediatrician's exchange and referred to ED for evaluation. Child was born at term without complications.
Tachycardia 120-130 Fever/sweats Chest Wall pain Fatigue Insomnia All resolved at 36 hours
Pt received shot within 5-10 minutes was having trouble breathing, administered Epi-pen, called 911 and monitored pt for changes in state. paramedics arrived and took over.