chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is a little blotchy lower then the injection site, near elbow; Hot to the touch Injection Site; the injection site became Red again; Injection Site was a little Red; Sore Injection Site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Injection Site was a little Red), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     no medical history was found.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included GLATIRAMER for Multiple sclerosis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Sore Injection Site). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again). On 02-Feb-2021, the patient experienced RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow). On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow), VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment  drugs were provided by reporter.
Pt stated as she was walking out of facility 20 mins after injection, her upper torso and throat felt tingly. she was transported via wheelchair to observation where she was examined and placed on bed.  VS at 1042 am- BP 146/90; pulse 70, resp 20, O2 100%. Pt given cold water which she tolerated; throat had no signs of swelling or redness at any time.  VS @11:15 a.m.-BP 134/86, pulse 65, resp. 16; O2 98%; VS at 11:25 a.m. standing after ambulating 10 feet - BP 127/79, pulse 72, resp 16, O2 98.  Pt states she is feeling ready to go home with husband who is accompanying her.  Transported to exit via wheelchair and advised to inform PCP of event.
Fainted with in 10 seconds, was out about 10 seconds.  Felt warm for about 15 minutes, laid down for roughly 20-25 minutes.  felt fine afterwards and was able to leave on his own.  Patient stated that he has a history of fainting during shots or lab tests but did not faint during his flu shot last year
Cellulitis of left upper extremity (Primary) Comments: #2 Covid last week. Worsening left deltoid tenderness/redness/itching since. No fever. No SOB. Keflex now. Cool compress. Oral Zyrtec for itch. ROV 10 days Orders: -     cephalexin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 2 (two) times a day for 10 days.  Dispense: 20 each; Refill: 0
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 608 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started to faint, pupils looked dilated and she was sweating and her palms appeared blue.  I administered benadryl in case she was having an allergic reaction.  Patient was breathing,  had a pulse and we sat her down and she started to wake up.  Her oxygen and blood pressure were normal and she had normal color after 15 minutes.  We iced the back of her neck and she started feeling better. She was able to drink water, and eventually had a pretzel with salt.   She walked around the store a little and then was fine and left. Probably 30 minutes total
Localized erythema around injection site, low grade fever - starting morning of 4/26/2023
requested medical records, have not received them; per death certificate, pt died in Hospice facility with COVID 19 being the cause of death; pt had a positive COVID test on 9/7/21
Soreness in arm; then welts the size of silver dollars across the upper arm.  Very sore/tender to the touch two days later.
Sore arm for all three covid-19 vaccine; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) and PAIN (Pain). At the time of the report, PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) had resolved and PAIN (Pain) outcome was unknown. Not Provided          The patient reported that RINVOQ was not working and needed to use another medication for the full effect of her feeling well. She found out that she was not supposed to take out RINVOQ pills to stored them in her weekly pill box so they were not as effective. If she would have kept them in stored bottle. She immediately changed that.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
chills; Cramps; achy; feeling feverish/mild fever; achy and it feels like someone punched me in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 65-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via intramuscularly in left bicep (left arm) on 15Mar2021 in after noon (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, # EN6201) via intramuscularly, administered in left bicep on 19Feb2021 at 2:40pm as single dose for covid-19 immunisation. The patient has no medical history and concomitant medication were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that after receiving the second dose of vaccine in Mar2021 the patient experienced feeling feverish/mild fever and achy and it feels like someone punched her in her chest. She was achy overnight and started having cramps. Clarified that she noticed over all achiness about 7:00AM this morning. She was achy overall. Her achiness has improved, now it was just in her back and shoulders. Patient stated regarding mild fever as she thinks that it started during the night while she was sleeping. She took her temperature about 8:00 am this morning, she retook her temperature about an hour ago and it was still 99.9. She thinks it has improved but she does not know for sure because she has not retaken it again yet. On 16Mar2021 patient experienced cramps which are acute and on 16Mar2021 at 07:00 in the morning the patient experienced chills. Therapeutic measures were taken as a result of cramps. Treatment included she took a couple of Tylenol yesterday. The outcome of the fever was unknown and was recovering from the events of chest pain and ache and was recovered from the events of chills and cramps on 16Mar2021.   No follow-up attempts are possible. No further information is expected.
Swelling/erythema/induration-3cm radius around inject site; hyperpyrexia (t105 ax according to parent) for 48-72 hrs;
Fever, Tmax 101F starting on 12/2. Resolved 12/4. Progressive pruritic erythematous rash starting at vaccine site and progressing to torso and scalp starting on 12/5.
Patient presented to emergency clinic with hives/ itching on chest, arms, and shoulders.  He had trouble breathingg, was dizzy, nauseous.  Dr felt patient had an allergic reaction to the shingrix because he has had the flu shot for years without adverse effect.  They told the patient to stay hydrated.  Today, 4 days later he is still reporting fatigue, blurred vision, nausea, and issues with his hearing.  His home healthcare worker followed up with his primary care doctor.  Primary care doctor office is monitoring, but told him to stay hydrated as they feel the symptoms will pass.
pt recv vax; devel arthritis especially in large joints & a rash; an IGG rubella test revealed that pt was not immune;pt had visited 5 MD and was hosp;at time of rpt,sx persisted;to see MMR specialist;
1hr post vax pt had 30min episode of dizziness resolved w/o incident but recurred x 2 daily x 1wk;lasting 1min;
suspected vaccination failure; shingles; Painful; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   The patient's past medical history included shingles (33 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID 19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. In 2021, unknown after receiving Shingles vaccine and about 6 months after receiving Covid vaccine, the patient came down with shingles.  It was painful enough but not debilitating like it could be.  The reporter stated that, there were reports of shingles being triggered within the 6 weeks or so post Covid vaccine. It was unknown if the reporter considered the shingles and pain to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
A sales representative reported that a pt received the 1st dose of Prevnar on 10/5/00 and the next morning, developed hoarseness. As of 10/12/00, no further information was available.
Itchy, redness hives started on back, progressed to abdomen. Up neck and down arms and legs by 10/20/18.
Upper arm still disconfirm; Aches in the arm or the discomfort on the arm, is minimal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE) and ANASTROZOLE for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal). At the time of the report, VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal) was resolving.      Treatment information was not reported.
Ten minutes after the Flu shot, I had sever pain in my entire left arm. The next morning, I had swollen lymph nodes and a lot of swelling in my neck. Left side pain continued for 5-7 days. Swelling 6 weeks. Still swelling in neck.
Patient developed chills after shot, then Diarrhea/upset stomach for 4 days. Soreness and muscle pain in shoulder making it painful to lift arm for 1 week.
Patient began running high fever and shaking with chills (described as tremors. fever reached 103 was brought down to 101 with APAP. By 10:30am the next day fever was gone.
Allergic post injection reaction. Flushed, urticaria, swelling to neck, itchiness to neck, hands, feet, throat, mild dyspnea, transitory shortness of breath.
Second vaccination with Shingrix has been delayed due to Covid; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Second vaccination with Shingrix has been delayed due to Covid). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The patient self-reported this case. The patient reported that her second vaccination with Shingrix had been delayed due to Covid.  No further information was known. Consented to follow-up was not asked.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. Diagnosed covid positive:07/26/21 Symptom onset: Exposure:Travel Symptoms: Asymptomatic
(Lt) deltoid w/some erythema & edema. Has decreased since yesterday (pt had long sleeve shirt on, swelling noticed yesterday).
facial paralysis; congestive heart failure; postherpetic neuralgia; vision problems; trigeminal neuralgia; Information has been received from a lawyer and a currently 67 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently (date not reported), the patient was treated by a provider for postherpetic neuralgia, vision problems, facial paralysis, congestive heart failure and trigeminal neuralgia. The patient claimed following damages as a result of zoster vaccine live (ZOSTAVAX): injury to themselves and economic losses. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related.   Upon internal review, the events of facial paralysis and cardiac failure congestive were determined to be medically significant.
Patient is fully vaccinated.  Hospitalized on 12/25/2021.  COVID + on 12/25/2021.  91-year-old female patient presented with past medical history of hypertension, chronic pain, dementia, depression, and end-stage renal failure, presented to ED due to rectal bleeding that started today.  The patient is alert and oriented x2, and cannot give a clear history, though she reports that she had dark black rectal bleeding today and has never had this in the past. Assessment/Treatment:  acute GI bleed, HG 7.8 PRBC transfusion, DC heparin, COVID viral pneumonia:  O2 sat 88% CXR Mild worsened aeration of the lung bases.  supplemental oxygen, decadron, remdesivir, AKI: cr 2.16. + for thrombocytopenia.  Patient discharged
Rash, 03/24/06 blanching macular, 03/27/06 mac/pap rash on trunk and legs. 4/3/06, edema eyes and nose purpuric rash.
Intense sensation of trembling like I have low blood sugar; Breathing feels slowed; Intense fatigue; Everything is slowed.; This is a spontaneous report from a contactable consumer, the patient. A 32-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 right arm on 08Mar2021 at 15:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), anxiety, bipolar disorder and temporomandibular joint disorder (TMJ disorder). The patient had known allergies to lavender and sulfa drugs. Concomitant medications included diazepam (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), curcuma longa rhizome (TURMERIC) and unspecified women's multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. 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 vaccination. On 08Mar2021 at 16:45, the patient experienced intense fatigue, intense sensation of trembling like the patient had low blood sugar, breathing felt slowed and everything was slowed. 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 had not been tested for COVID-19. The clinical outcome of the events intense sensation of trembling like the patient had low blood sugar, breathing felt slowed, everything was slowed and intense fatigue were not resolved 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.
Patient presented with shortness of breath, chest pressure, dizzy.  Patient states that it was from TB and Influenza vaccines that she received 2 days ago.  No fever was present, no redness/swelling at injection sites.  No oral mucusol edema.  Lungs clear.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. 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 EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use), PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine past the 30 day beyond use) and PRODUCT STORAGE ERROR (Administered with vaccine past the 30 day beyond use). No concomitant medications was reported. No treatment drug details was reported. Reporter did not allow further contact
aching arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (aching arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (aching arm). At the time of the report, VACCINATION SITE PAIN (aching arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-JUN-2013, the patient was inoculated with ZOSTAVAX at a medical facility as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-SEP-2015, the patient was treated at the same medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Mom reports that after receiving Hep A vaccine #2, patient had swelling at injection site, site was warm to touch, red and itchy. It resolved in about 1 week.
Had rather abrupt onset of severe nausea, extreme chills to the point of shivering on the floor, wrapped in two thick blankets and having a space heater blowing at me.  Lasted ~4 hours then subsided without apparent sequela.  Never vomited.  In contact, I had COVID the first week of October and had ongoing dyspnea with exertion for months afterward, not really fully resolved until mid-January, after I'd had the first dose of the Moderna vaccine.
I went home after the shot.  Not long after I felt 'clammy' and eventually vomited, had some diarrhea, was very tired, and had mild shortness of breath.  I laid down and eventually fell asleep for several hours.  I took it easy around the house for the rest of the evening but felt better with some mild diarrhea. I slept okay that night and have been fine since.  Am not sure if this was a reaction or not to the flu shot.  I have had many flu shots over the years but have never had a reaction.