chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red spot as big as a half dollar; itchy; swelling; redness at the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot as big as a half dollar), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness at the site) and VACCINATION SITE SWELLING (swelling) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cholesterol and Arthritis. Concomitant products included ALLOPURINOL for Arthritis, ATORVASTATIN for Cholesterol, INSULIN DETEMIR (LEVEMIR) and SITAGLIPTIN PHOSPHATE (JANVIA) for Diabetes mellitus, CALCIUM and MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy, HCTZ for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the site). On 30-Jan-2021, the patient experienced RASH MACULAR (red spot as big as a half dollar), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (swelling). The patient was treated with HYDROCORTISONE at a dose of UNK, tid. On 28-Jan-2021, VACCINATION SITE ERYTHEMA (redness at the site) had resolved. At the time of the report, RASH MACULAR (red spot as big as a half dollar), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 16AUG96 & dx w/chickenpox 25FEB98;
pt recvd vax 14NOV95 & 27NOV95 pt devel a fever & 28 blisters located on abd & back (range not recorded);no further details were provided;
2 days later, she noticed hives on her arms where the injections had been given and then a couple weeks later after being in the sun, she developed hives again in the same areas.
Patient reports feeling terrible, difficult to get out of bed on Sunday 8/27. Presents to pharmacy on 8/28, right arm is red, tender, with palpable lump.
Pt came to clinic (7/24) after receiving pneumonia vaccine on 7/21/08. Pt states upon awakening morning after injection she had a lot of twisting stiffness in arm muscle. The following am awoke with reddened area which has increased in size. Area is warm to touch. Scattered redness to 1/2 of upper arm area.
For several days, immediately following each dose, I had terrible restless legs/body that lasted 7 days after the first dose and about 3 days after the second dose. Then it went away.  March 3, 2021, I developed painful, raised, erythematous lesions that developed large blisters on top. March 18, 2021 and March 19, 2021 it happened again.
Patient received a higher than recommended Pfizer vaccine (12+) formulation for the 1st dose. Patients parents were informed, side effects were reviwed with parents and a follow up phone call was done.  No adverse symptoms were felt.
Within the first couple days, the pt became intermittently dizzy and nauseated, with an increase in tremors, leading to a fall and a hip and wrist fracture. He progressed over a few more days, to having a low grade fever. 100.1. and a cough and shortness of breath.
Lower mouth gums to cheeks began to swell on both sides; Lip began to swell and cracked and bled; Lip began to swell and cracked and bled; Lip began to swell and cracked and bled; lip swelled like an allergic reaction; This is a spontaneous report from a contactable consumer. A 58-year-old female patient (non pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection; (Batch/Lot Number: ER8731; Expiry date: 31Jul2021), intramuscularly, in left arm on 14Apr2021 at 10:30, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 58-years-old). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient was allergic to Unpasteurized eggs. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: EW0165), intramuscularly, in left arm on 06May2021 1:00, as DOSE 2, SINGLE for covid-19 immunization. The patient's concomitant medication was not reported. On 15Apr2021 at 12:00, the patient developed swollen lips and Lips swelled like an allergic reaction. On 16Apr2021 at 05:00, after 2 days of the vaccination the patient's lip began to swell and cracked and bled. On 17Apr2021, 3 days after vaccination her lower mouth gums to cheeks began to swell on both sides. Lips swelled like an allergic reaction and remained swollen for 3 months. Therapeutic measures were taken as a result for the events. The patient received antihistamine treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
My thyroid were unleveled and was given treatment to treat the hyperthyroidism auto immune condition
Edema to eyelids-face, runny nose, conjunctivitis, blotchy skin rash, no breaking;
Progressive numbness, tingling, burning, and pain in hands, legs, hips, back, right shoulder and feet. Difficulty walking. Developed bladder incontinence. Chest heaviness.
Difficulty moving arm, no swelling - started soon after injection, improved after first day then worsened again. Went to urgent care, MD saw no swelling or fluid build up, prescribed ibuprofen - planned to follow up with PCP.
Mild flu-like symptoms (chills, fever, mild cough).  Also sore arm at injection site.  Treated with Acetaminophen.   36 hours after injection, symptoms are subsiding considerably.
Information has been received from a consumer concerning her 14 year old daughter with sulfa allergy and with no previous medical history reported who on 15-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot number 658490/0802U) and on 16-JUN-2008 with the second dose of GARDASIL (Lot number 659180/1758U).  Concomitant  therapy included LEVOTHYROXINE Na.  Four months ago, approximately in September 2008, the patient experienced joint pain in her ankles and wrists after receiving GARDASIL.  The reporter also noted that the patient had experienced hypothyroidism after she received GARDASIL.  The patient's joint pain in her ankles and wrists and hypothyroidism persisted.  Bone scan and blood work were performed to test for lymes disease (results were not provided).  The patient sought medical attention with the physician.   The consumer wanted to know if there have been any reports of these symptoms associated with the specific lot numbers that her daughter had received.  A lot check has been initiated.  Additional information has been requested. A standard lot check investigation was performed. All in-process qualit checks for the lot number in question were satisfactory. The lot met the requirments and was released. Additional information has been requested.   8/3/09 Records received from PCP for dates 10/2007 to 6/2008. In for WCC 10/15/07 with assessment: Healthy. Acne. 3 vax given. Pt returned 11/29/07 with c/o worsening H/As, most recent x 4 days, not resolving. Now more frequent.  Painful mass on head. Assess:  H/A- some migrainous characteristics. Lump/mass on head. Sent for head CT which was abnormal.  Visual exam 12/7/07 doubt ocular origin of H/A.  Referred to neurology. Thyroid studies noted to be abnormal.  Now with c/o fatigue.  Missing multiple days of school.  7/7/09 PCP MR received. OV for HPV vax on 6/16/08 (1758U). OV 8/14/08 for itchy, painful rash.  Erythematous papular lesions with excoriation of center noted.  Culture (-). OV 12/4/08 with c/o 1-2 month hx of bilateral wrist pain and stiffness and more acute heel pain. Having difficulty walking. PE (+) for diffuse tenderness over dorsal wrists and with dorsiflexion, ball of foot. Sent for labs. Assess:  Joint pain. Return 1/5/09, 4/22/09 with same c/o.  Ortho consult 4/20/09. Dx:  Tendonitis.  Joint Pain.   7/23/09 Medical records received DOS 6/20/08 to 6/26/09. Assessment: Autoimmune Hypothyroidism. Patient continues to be on thyroid replacement, has chronic migraine headaches, and had a recent repair of a left meningeal cyst. Surgical scar left fronto-parietal junction. Insect bites on both legs that are blistering. Joint stiffness and achiness involving ankles, wrists, fingers. Right heel pain. Redness over wrists. Bilateral ankle pain. Ligamentous laxity. Trouble sleeping. Elevated systolic blood pressure.
This one lady didn't have cancer and she was dead in three weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "This one lady didn't have cancer and she was dead in three weeks". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: Caller is a consumer who states "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She states "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She states her sister has been doing a lot of research online, but she's not sure what sources she's reading.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: This one lady didn't have cancer and she was dead in three weeks
Mother states child had 3 shots on 7/22/13 - KINRIX (L) Deltoid), MMR ((R) upper arm subq), Varicella (L) upper arm Sub. States (L) upper arm in deltoid area is swollen, red, and hot. States he is able to move his arm, play and only complains when the area is touched.
Rushed to the hospital the day after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Rushed to the hospital the day after getting vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Rushed to the hospital the day after getting vaccine) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Rushed to the hospital the day after getting vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided.  The reporter stated that the patient who was the mother-in-lawof the reporter rushed to the hospital the day after getting the vaccine.  Company comment:  This case concerns a female patient with no relevant medical history who experienced serious unexpected event of hospitalization, that occurred a day after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. No further details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-447283, MOD-2022-447298, MOD-2022-447299 (Patient Link).; Sender's Comments: This case concerns a female patient with no relevant medical history who experienced serious unexpected event of hospitalization, that occurred a day after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. No further details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. In approximately November 2013 (about a month ago) the patient received ZOSTAVAX (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. Shortly after vaccination the patient had an anaphylactic reaction in approximately November 2013. It was reported that the patient sought for medical attention (unspecified medical attention). It was reported that the patient went back to the pharmacy on an unspecified date in 2013 to inform the pharmacist that the was OK. The pharmacist did not assess the seriousness of the event. Additional information has been requested.
Within less than 10 minutes after receiving the vaccine, the patient complained of swelling and numb sensation to lips and metallic taste in her mouth. No trouble breathing or swallowing. Seen in emergency room. Given Benadryl 25 mg  PO. At 1047 symptoms were all resolved and patient was discharged with instructions to take Benadryl 25 mg every 6 hour as needed. Return to ER if needed.
24 hours post vaccination febrile reaction. Temps as high as 104... continue to persist on 10/9. Temps fluctuate between 100 and 102 degrees Fahrenheit at present. Do not respond to TYLENOL, aspirin, or ibuprofen.
A report was received from a health care professional on 2/24/04 concerning a 61 year old male vaccinee who inadvertently received expired Fluvirin on an unspecified date in September 2003. On an unspecified date in September 2003, the vaccinee was inadvertently administered a dose of 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Described arms as feeling tingly, like icy hot was applies to both upper arms, woke up on Tues am with itching around the site of injections (both arms) hives with redness and swelling around injection site. Painful to move both UE.
Redness, swollen, and hardness at injection site (diameter of redness approx 1.5").
when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032712) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3032712) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE BREAKAGE (when the nurse was removing the grey cap twisting clockwise, it broke and they can't use the syringe with the vaccine in it).    No concomitant or treatment medications were provided.  The pharmacist reported that they had one of their PFS of Spikevax the cap broke off of it before they could even get it off, like when the nurse was removing the grey cap twisting clockwise, it was broken and they could not use the syringe with the vaccine in it.  On 02-Nov-2023, shipment of the vaccine was received.  It was reported that the issue was not related to difficulty drawing the vaccine into the syringe, the syringe was not missing and it was not leaking. Did not notice any liquid, or staining in the carton/blister pack, PFS was not broken when received it, until tried to twist the cap it broke and there was no any issues noticed with the carton/packaging. Vaccines were put in the fridge at least 1 hour before administering, temperature was freezer set at -21°C and temperature was refrigerator set at 4.5°C. Currently the PFS was in a ziploc bag in the fridge.  The Device problem code for Spikevax syringe include FDA code 2588, RA code A0203 which include Defective Device.  The device was malfunctioned, and the malfunction type was CIRM.
Pt tested for COVID 19 at end of hospitalization for admit into HCF, found positive and asymptomatic
Patient sat for about 5 minutes after vaccination and then passed out.  I came to her and she had already come to; I checked her blood pressure and it was low - 78/59 and pulse was 52.  We offered her juice and water and moved her to another room and had her put her feet up as much as she was comfortable.  We checked her blood pressure again 9 minutes later and it had come up to 110/79 and pulse 61.  Pt's color had come back to her face and she reported feeling much better.  Pt declined emergency care.
10 minutes after getting vaccine , half of her tongue, left part of face (cheek), and entire left arm felt numb. It has slowly improved and there are now some days that she feels more numbness. There is no eye tearing, no drooping face, no problems hearing, no change in eyesight, no change in smell, no change in smell.  Patient had soreness in her arm near the shot site but this improved in two days.
Pt presented with a reddened arm that vaccine was administered in and appeared to have a rash indicating a possible allergic response.
food poisoning; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting). At the time of the report, FOOD POISONING (food poisoning), DIARRHOEA (diarrhea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had food poisoning and had to miss his second dose. He experienced vomiting and diarrhea. The patient wanted to know when he could receive the second dose since he missed his first.  No treatment information was provided.
I couldn't get like enough oxygen; I ran a fever of 101; this triggered my asthma I just didn't have an attack.; short of breath; dizziness; extreme shakiness throughout my whole body; This is a spontaneous report from a contactable consumer. A 30-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:15 (Batch/Lot Number: EL9264) as single dose for covid-19 immunisation. Medical history included asthma and allergies to sulfa drugs and wheat/gluten. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL), ibuprofen (IBUPROFEN) and guaifenesin (MUCINEX). On 17Feb2021 19:00 the patient had an asthma, not all of the time to where she needs her inhaler for a lot of events. But this triggered her asthma she just did not have an attack. She was short of breath, had dizziness, and felt like she could not get like enough oxygen in it was hard to explain. Her inhaler did help this, she had this occurrence 3 times the first day of the vaccine. The same night (17Feb2021) she started having extreme shakiness throughout whole body and it had not stopped since even in her face. She took a video if that helps as well. But, even right now two days later she still having full body tremors 24-7. She ran a fever of 101 the day after off and on all day but she no longer have been feverish the third day at all, the tremors remain. The patient underwent lab tests and procedures which included body temperature: 101, oxygen saturation: couldn't get like enough oxygen on. Therapeutic measures were taken as a result of asthma, dyspnoea, dizziness and oxygen saturation decreased. No treatment received for pyrexia and tremor. Outcome of the event asthma, dyspnoea, and dizziness was recovered on unknown date. Tremor and oxygen saturation decreased was not recovered, pyrexia was recovered on unspecified date in Feb2021.
Sudden onset of blurry vision, headache and fever. At 7:00 PM, patient states that she was immobile due to incessant shivering. Was concerned for her life and felt as though her heart was beating out of her chest. Patient contemplated calling an ambulance.
Patient got primary series of Moderna (12/28/2020 & 1/25/2021). Chose Janssen for heterologous booster (11/3/2021).  Reported 11/10/2021 chest pain, SOB, leg and arm pain, difficulty to find resting position, peaked at 36 hours from onset, lasted 48 hours, resolved without treatment.  Time elapsed without issue, but then patient was hospitalized 3 different times (12/24/2021 , 1/17/2022, and 2/14/2022) diagnosed with Idiopathic recurrent pericarditis , treated with Aspirin and Prednisone. Hospitalized.
Cellulitis developed around vaccine site. Positive fluid filled pustules at margin of cellulitis. Culture sent.
Mom states child had 103 temp in afternoon. That evening @ 7PM had 15 min sz. Brought to hosp & hospitalized overnight.
Received vaccine on  1/9/21.  Had mild sore arm on  1/10 that lasted for 24 hours.  On 1/16/21, developed pain and a lump in left shoulder that spread to left upper arm on 1/1.  Hot, firm, and red spreading across upper left bicep and lateral/anterior shoulder.  Extended area of redness, firmness and warmth on 1/18.  Started keflex on 1/17/21 evening, switched to docycline this morning on 1/18/21. Overall fatigue, left arm pain and tenderness mild and mild myalgias and chills
Staph abscess and fistula formation at site of injections on right thigh after 4 month vaccines (as below) were given. Patient required surgery 9/30/05. Patient had similar reaction to left thigh when 2 month shots were given at another facility.
Up fr nap temp 101(ax); Body limp, twitching; Eyes rolled back in head, nonresponsive, breathing-epi lasted 5 min; To Hosp; Nonraised rash, stomach & chest-MD appt today; MD felt fever & convuls not vax related; DT next time;Also ear infect