chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is the 2nd dose of  Pfizer COVID vaccine.  Patient is allergic to tree nuts but ok on the first shot.  Patient complained of throat tightness 10 minutes after the injection. She was given water and monitored in front of the pharmacy.  She still complained of throat tightness and asked for Epi-pen injection which she had used before.  She immediately felt relief after she injected 1 Epi-pen into her right thigh.  After confirming that she has non-expired Epi-pen at home and she felt good enough, she was discharged home.
- general sense of feeling weaker than normal. - feeling of tense and restless muscles (especially legs), a sense that my body was struggling. - inability to sleep. That lasted about 30 hours. I realize this is probably a mild symptom, and probably a normal reaction.  But you might need to know that.
Sore arm; A little bit of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder NOS (Autoimmune).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. It was reported that the patient did not have any issues at the time of reporting.   This case was linked to MOD-2021-406181, MOD-2021-406185 (Patient Link).
Dyskinesia of the tongue, left face, Jaw, and Lips; Delayed Reaction; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ehlers-Danlos syndrome, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Erythromelalgia, Cystitis interstitial, Delayed gastric emptying, Acid reflux (esophageal), Osteopenia, Occipital neuralgia and Neuralgia. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON), PROPRANOLOL, DEXLANSOPRAZOLE (DEXILANT), FAMOTIDINE, ETHINYLESTRADIOL, LEVONORGESTREL (CAMRESE) and ALPRAZOLAM (XANAX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) (seriousness criterion hospitalization) and INJECTION SITE REACTION (Delayed Reaction). On 06-Feb-2021, DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) and INJECTION SITE REACTION (Delayed Reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medication included Hizentai for unknown indication.  Treatments: Aleve, Advil, Tylenol, Cromolyn Sodium 100mg/5ml orally daily, and applying Cromolyn Sodium to face topically, Naltrexone 4.5mg, Zirbel , Myrbetriq 60mg daily, Ondansetron 8mg PRN Nausea, Hydroxyzine 25mg, Hemax , Hyoscyamine 0.1 Oral PRN.     This case was linked to MOD-2021-036762 (Patient Link).; Sender's Comments: This case concerns a 39-year-old female with a serious unexpected event of dyskinesia and expected injection site reaction. Event onset 16 days after first dose. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses of ROTATEQ immunization series, lot number L033545, expiration date: 30-MAY-2017, lot number L048854, expiration date: 31-AUG-2017 and lot number L035511, expiration date: 21-MAY-2017, orally, (does was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Adult patient inadvertently received pediatric dose; Adult patient inadvertently received pediatric dose of Engerix b; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: License practical nurse reported that an adult patient inadvertently received a pediatric dose of Engerix b instead of the adult dose. The patient's demographic details were asked, but health care professional did not have the information neither lot number or expiration date. The follow up could not be asked since health care professional hung up while trying to be transferred to 2nd line agent. No further details could be collected. The reporter did not consent to follow up. Additional Supportive Information: Adult patient inadvertently received a pediatric dose of Engerix b instead of the adult dose, which led to accidental underdose and adult use of a child product.
Pt has hives for 2-3 days after injection starting 2 hours after injection. She also stated  redness/itching to injection site. In addition fatigue after injection.
03/25/2021: Waking up from chills several times throughout the night following injection, fever reaching at least 100.1 F (one of three time points body temperature was measured while awake), body aches, headache, fatigue, sleepiness, poor appetite. Treated with one dose of Tylenol, rest, and drinking fluids. 03/26/2021: Fatigue 03/27/2021: Fatigue 03/28/2021; Fatigue
Dark brown to black menses begin and lasted 3 days. LMP 8/18-8/20 and was not due to start until 9/16/21., subsequently begin bleeding again, 10/8-10/9. Additional reactions included tiredness and brain fog.
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own.  employee is 14 weeks pregnant.
Mom reports child has had diarrhea since receiving vaccination. Reports giving child Immodium but diarrhea returns. Mom states will take child to physician on 9/23/16 for diarrhea.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU lot # M020902/expiration date - 18-JUL-2017. Temperature was 6.7 F(Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; This is a spontaneous report received from a Pfizer sponsored program. A contactable male consumer (patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunization on 29Mar2021. Relevant history and concomitant drugs were unknown. The patient experienced fever and started taking acetaminophen for fever. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt heaviness in left arm; Could not raise arm above shoulder; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 75-years-old) at 13:30, as a single dose for COVID-19 immunisation. Medical history included osteoporosis (Osteoporosity), hypothyroidism (hypothyroid), opioid allergy and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021at 19:00, the patient felt heaviness in left arm and could not raise arm above shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient did not test for COVID-19. The clinical outcome of the events felt heaviness in left arm, could not raise arm above shoulder was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Terrible body aches starting at 8pm on April 1st.  Then had the chills.  Was able to take ibuprofen and slept for a bit.  Next morning April 2, got a migraine where it hurt to open my eyes.  Had that for about 2 hours then got better.  Also, I had trouble eating.  I would take a small bite of crackers and feel like I was going to throw up.  Took me a long time to eat a package of crackers and to drink 1 whole bottle of gatorade.  I took more ibuprofen through the day and that helped.  Around 5pm that night I was able to eat a little more and drink some with out feeling sick to my body.  Around 9pm that night headache came back and I went to bed for the night.  Today April 3 I feel a lot better.  Body still aches a bit and feels like I?ve been sick for 2 days so will probably take today and tomorrow to fully recoup.  No headache today.  Just small aches and tired.
during injection, he experienced intense prolonged pain; This case was reported by a consumer via local affiliate and described the occurrence of injection site pain in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter experienced intense prolonged pain and the liquid was pooling under his skin causing the administrator to leave the needle in his arm for a prolonged period of time. The patient commented to the administrator that she was hurting him, and she replied that this was how the Shingrix vaccine worked. Eventually liquid dissipated into the body and the administrator removed the needle. No local or systemic reactions were reported.
A swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A swollen arm) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (A swollen arm). At the time of the report, PERIPHERAL SWELLING (A swollen arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Approximately 50 minutes after getting patient her first shot of Pfizer, she quickly complained of the following symptoms in this order: metal taste in mouth, lips burning and going numb, I can't feel my lips and then my lower lip is swelling and then less swelling in the upper lip. No additional symptoms were experienced other then surprise and worry.
Fever 102F consistent, able to decrease temp some with tylenol/ Redding around L thigh injection (IPV) visualized red spots, Varicelliform rash per MD.
A few hours after his vaccine, patient developed right flank pain, chills, fever, bilateral diffuse lower extremity pain, and increased heart rate.  He presented to urgent care and was transferred to the ED. He was febrile at 100.4. UA was negative. CBC, CMP were normal. COVID 19 test was negative. EKG was normal. CT abd/pelvis only showed circumferential bladder wall thickening; no evidence of pyelonephritis or nephrolithasis. Urine culture was not sent. Was given Tylenol with slight relief and then Toradol injection w/o significant relief. Continued to have lower extremity pain and some mild residual right flank pain after discharge from the ED. Also was very nauseated and had difficulty eating.  The next day, was able to eat some chicken noodle soup but had some odynophagia with that.  Fever resolved about one day after his ED visit.  After 3 days, he was able to eat solid food again w/o nausea or esophageal pain.
severe chills that lasted at least 9 hours, lessened but still periods of trying to stay warm for the next 24 hours joint pain for 36 hours nausea for 12 hours headaches for 36 hours
I lost my voice; Very hoarse; Had covid arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 14:00 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "peripheral neurorapthy" (unspecified if ongoing), notes: Verbatim: peripheral neurorapthy; "Allergies: Shellfish" (unspecified if ongoing), notes: Verbatim: Shellfish; "allergies: contrast dye" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin"; Sulfa drugs, reaction(s): "known allergies: sulfa drugs". The following information was reported: APHONIA (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "I lost my voice"; DYSPHONIA (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "Very hoarse"; LIMB DISCOMFORT (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "Had covid arm". The events "i lost my voice", "very hoarse" and "had covid arm" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of aphonia, dysphonia, limb discomfort.  Additional information: Facility type vaccine was Hospital. Patient lost her voice/very hoarse the evening of the vaccine. It has not returned. It has been 2 weeks and 2 days. Patient went to urgent care and her family doctor who said to wait it out. Patient was scheduled to receive her 2nd dose this Sunday. Patient had allergies. She did not get anaphylaxis but lost her voice and had Covid arm. Patient had not received other vaccine in four weeks. She was under several other medications in two weeks. She was not tested positive prior vaccination and was not tested positive after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-JUL-2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-JAN-2017, the patient was treated by a physician's assistant at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
This morning noted redness to upper left arm deltoid area, 7/29/03 soreness, noted today redness, warm to touch, slight swelling and firmness, complaints of arm hurts to raise. Pt's private physician gave Keflex and steroid. Dx reaction from Td.
raised 3 to 4" circular inflammation @ inj site;hot to touch w/pain-knee & hip became red & painful-knee filled w/fluid;
lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Asthma, hypertension, covid prior vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); montelukast sodium (SINGULAIR); losartan; HCTZ; unspecified product "D". The patient previously took erythromycin and experienced allergy. The patient received the first dose of bnt162b2, at the age of 70-year-old, via an unspecified route of administration, administered in right arm on 13Mar2021 11:00 as single dose for covid-19 immunization and experienced fatigue and sore arm. The patient experienced lungs feel congested, chest tightness on 04Apr2021 03:00; chills, fever and inflammation on 03Apr2021. Chills and fever Sat. night into Sunday, fever lasted until Monday 05Apr. Chest tightness, lungs feel congested. Went to doctor, he thought inflammation from vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The patient was not pregnant. The outcome of the events Fever was recovered on 05Apr2021, other events was recovering.  Information on lot/batch number has been requested.
Appears the dose was given in the subcutaneious fat not in the deltoid muscle on the left arm, there is a slight bruise and a 3 in diameter ride patch on left arm, slightly raised
Felt dizzy and lightheaded 10 minutes after injection.  Client drank some water and reclined in cot.  BP 142/71 Pulse - 80 O2 Sat 100% Client was evaluated by EMS, and felt better after resting for 15-20 more minutes. Total observation time after vaccine 45 minutes.  Client reports "feeling more like myself"
Rash and pustules beginning on left hand and spreading to hands, arms, trunk, thighs, and legs, persisting to current date, but improving.
calf muscle hurting, knees ache, shortness of breath. unbalance, loss of muscle,    no diagnosis
First dose / on oct 2019 / did not receive the second dose due to Covid; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid-19. The reporter wanted to know that if patient needs to take the next dose or revaccinate. No other details of the vaccine available. The reporter consented to follow up.
I experienced chest spasms early morning hours on September 2nd. They started around 02:00AM. They were on the left side of my chest. I took one baby aspirin at 02:00AM and one baby aspirin at 04:00AM. They continued until that afternoon. I went to the emergency room around noon after trying to get an appointment with my cardiologist for an EKG. I was there for five hours. The spasms weren't painful, but they were concerning. It felt like someone was squeezing and letting go of my body repeatedly. They gave me a chewable aspirin in the emergency room. They ruled out a heart attack.
rash after her first Shingrix dose; hives and rash after her first Shingrix dose; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and hives. The action taken with Shingrix was unknown. On an unknown date, the outcome of the rash and hives were unknown.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The reporter declined to provide patient information. The reporter did not consent to follow up. The case has been  linked with case US2021056506, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021056506:same reporter