chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm got very red and started swelling immediately after the injection. She had a small knot in her arm at the site of the injection. I gave her 10 mls of Diphenhydramine 12.5mg/5ml. I monitored her for 30 minutes. During that time, she complained of burning and tingling down the entire left arm. I continued to monitor her. The redness dissipated and the swelling was reduced. She reported feeling fine the entire time. I spoke with her about 7 hours after the injection and she said she was feeling fine. She said the injection site was sore but the swelling, redness, tingling and burning were gone. She was able to resume normal work activities shortly after the injection.
One week after injection on 1/24, injection site became very itchy, red, sore and swollen. Two days later is slightly less sore but still very red and swollen.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The caller reported a sore left arm injection site with dose of SHINGRIX. The reporter did not give consent to follow up. The caller refused medical doctor contact regarding this event.
Headache, Sedation, Arthralgia & NauseaVomiting Narrative:
Third degree heart block-unknown etiology symptoms began Nov 03 with weakness and grew progressively worse to include SOB and significant weakness. Heart block diagnosed 1/21/04. Pacemaker (permanent) inserted 2/28/04.
Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 information was provided.  No concomitant medication was provided.
Lymph nodes in groin (both sides) hurt; Could hardly walk; Terrible back ache; Moon shaped red rash on arm; Didn't feel well; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Moon shaped red rash on arm), VACCINATION COMPLICATION (Didn't feel well), LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches). On 03-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Moon shaped red rash on arm). On 04-Apr-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache). On 02-Apr-2021, VACCINATION COMPLICATION (Didn't feel well) and MYALGIA (Aches) had resolved. On 08-Apr-2021, LYMPH NODE PAIN (Lymph nodes in groin (both sides) hurt), GAIT DISTURBANCE (Could hardly walk) and BACK PAIN (Terrible back ache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Moon shaped red rash on arm) outcome was unknown.            No concomitant information was reported. Treatment for lymph node pain in the groin and terrible backache included heat and rest. Action taken with mRNA-1273 in response to the events was not applicable.
A week after receiving the vaccine I noticed a  bright red warm 2" x2" circle on my arm. (possible cellulitis?) I called my PCP but they wanted me to notify you to see what I should do about it.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route of administration, lot# were not reported). The patient discovered that she was pregnant on unspecified date. The date of last menstrual period (LMP) and estimated delivery date (EDD) was unknown. The outcome of exposure during pregnancy and relatedness between exposure during pregnancy and (Oka/Merck) VARIVAX were not provided. Additional information has been requested.
Hepatitis B given with Comvax. Hep A ordered. No adverse side effects noted in office.
(L) thigh with red area tender blister area over injection site. Multiple red areas with m.
Arm soreness; Body chills; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 125K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea). On 29-Dec-2020, PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Arrived w/ weakness and cough x1 month. Admit for COVID pna dx in ER. Out of window for monoclonal or remdesivir. Received  steroids, toci, rocephin and zithromax, singulair, zinc, pepcid, emergent dialysis. Developed ARDS. O2 needs progressed to 100% Bipap. Deteroirated and placed on comfort care. Expired in hospital.
Pain in Jaw on right side Eye and lip swelling swelling Pain in right arm radiating to finger  right shoulder pain radiating in neck, heavy feeling in neck, shoulder and arm Metallic taste
Mother states on return visit with other child that the pt complained of chest pain and palpitations and "felt bad" and had "sweating" lasting about 30 minutes beginning about 1 1/2 hour after vax was given. The pt had another episode about 24 hours post vax. This episode did not last as long as the 1st episode.
brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Feb2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (death, medically significant) with onset 29Dec2021, outcome "fatal", described as "brain bleed". He was 82 years old and in great shape. The patient date of death was 29Dec2021. The reported cause of death was cerebral haemorrhage. It was unknown if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: brain bleed
Patient was administered bivalent vaccine which was beyond the 30 use by date; No adverse event; They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported. The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old. No treatment details were reported. This case contains information for the 6th of 15th adult patients (2nd of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
This spontaneous report was received from a medical assistant concerning a patient of an unknown age (reported date of birth was later that adverse event's onset date) and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429, expiration date: 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Redness of the skin, beginning just below the site of injection and spreading outwards down and around the arm, and now almost reaching the wrist joint. Initially, the affected area was very warm, but, according to the patient, it is now less warm.
Patient experienced sharp stabbing/throbbing pain behind her ear that lasts ~10 seconds,; Neck hurt; Pt experienced sharp stabbing/throbbing pain behind her back of head that lasts ~10 seconds, then her headhurt; This is a spontaneous report from a non-contactable pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200) via an intramuscular route of administration on 26Mar2021(at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and asthma. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), famotidine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and vitamins nos (MVI) for unknown indication on unknown dates and unknown if ongoing. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) for unknown indication on unknown date and experienced hives and facial swelling. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced nausea and vomiting. On 02Apr2021, after first dose of Pfizer COVID-19 vaccine administration on 26Mar2021, the patient experienced sharp stabbing/throbbing pain behind her ear/back of head that lasted for 10 seconds, then her head and neck hurt.  Those events occurred similarly 5 times since the initial event. She was recommended to consult her primary care physician and had been referred to neurologist for follow-up. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events which included treatment with ASPIRIN, ibuprofen (MANUFACTURER UNKNOWN) and tizanidine (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events sharp stabbing/throbbing pain behind ear/back of head, then head and neck hurt were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 17 year old female patient who on 05-AUG-2009 was vaccinated intramuscular with the first and only dose of 0.5ml GARDASIL (lot # 663452/0671Y). Secondary suspected therapy included VARIVAX administered on 05-UG-2009. Other concomitant therapy included ADVAIR and MENACTRA administered on 05-AUG-2009. On 06-AUG-2009 the patient developed exertional vertigo and extreme fatigue. The patient was a Division 1 softball player and she had not been able to participate due to these symptoms. On 18-AUG-2009 the patient had syncope and ended up in the emergency room. she was not admitted. She will be seen in the office on 19-AUG-2009. The patient had sought the physician for medical attention on 11-AUG-2009. The patient had not recovered. The patient's exertional vertigo, extreme fatigue and syncope were considered to be disabling. Follow up information has been received from the physician concerning the 17 year old female patient who on 15-AUG-2009 had concomitantly received the second dose of VARIVAX (LOT# 664701/0726Y) and MENACTRA (LOT # U291944). On 18-AUG-2009, the patient had syncope and was taken to the Emergency room. The patient had a CT scan and laboratory tests. All testing was negative. The patient was not admitted to the hospital. The patient was seen by the physician on 19-aug-2009. The patient complained of nausea, dizzy and light-headedness on exertion. The physician stated that he was going to refer the patient to a cardiologist for evaluation. Additional information has been requested.  9/3/09 Received ER medical records of 8/18-8/19/2009. FINAL DX: dizziness w/evidence of mild heat exhaustion; possible HPV vaccine side effects.  Remained stable & d/c to home w/PCP f/u. Records reveal patient experienced dizziness & malaise since vaccines, with nausea & vomiting while playing sports on day of admission.  9/8/09 Received PCP record of 8/19/09 & vaccine records. FINAL DX: syncopy & nausea Records reveal seen in ER w/neg w/u.  Recovered. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 Neuro consult. DX: syncopal episodes of undetermined etiology. Poss. Adverse rx to gardasil vax.  Presenting SX: c/o dizziness and sick to stomach since 8/09. h/o syncopal episode seen in ER. c/o at time of onset of episodes of vision changes, hot/sweaty sensation, nausea, just prior to syncope. Pt. also c/o HA. Diagnostics ordered. 10/15/09. Neuro consult. Final DX: vasovagal episode associated with response to vax injection.
Pt received vaccine @1726 and 5 minutes later she developed tingling to her upper and lower lips. Assessment was normal and at 1757 her symptoms completely resolved and she was released to home
Started 2 days ago, red swollen and very painful to touch. Pt stopped in office today to have checked.
Rash present starting on day 12 after vaccination. Rash present on all extremities and neck. Not present on back or belly. Itchy.
pain in abdominal  area right front next morning,  skin extremely sensitive,  pain also  right back , rash started 4 days later, 5th day noticed blisters on  rash,  Doctor's appointment on 6th day confirmed Singles which I had as a teenager,    Given a prescription for Valacyclovir Hcl 1 GM 3 times a day.
Patient developed swelling of his lips, mouth and jaw and also had a red rash on his torso. He did not seek medical attention and did not take any BENADRYL. The swelling and rash spontaneously resolved within 24 hours.
This case was reported by a consumer and described the occurrence of injection site pain at shoulder in a 50-year-old female subject who was vaccinated with DTPA (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included allergic reaction to Cymbalta, allergy to Biaxin, allergy to cephalexin, allergy to Cipro, Levaquin allergy, sulfa allergy, lexapro allergy and Wellbutrin allergy. Concurrent medications included Zolpidem, Sertraline, Mirapex, Magnesium aspartate, Glucosamine chondroitin complex and Iron salt. Subject's previous vaccinations went uncomplicated. In 2014 (5-6 weeks prior to the reporting time), the subject received unspecified dose of DTPA (with small D + P) (unknown route, left arm; lot number not provided). In 2014, 1 to 2 weeks after vaccination with DTPA (with small D + P), the subject experienced injection site reaction (left shoulder) described as: joint pain, swelling, hard spot and hot to touch. The consumer mentioned the side effects that she was experiencing to the doctor's office when she was there for an appointment for her daughter. The consumer considered the events were disabling and clinically significant. The subject stated that the events did not require medical attention. The consumer considered the events were disabling and clinically significant. At the time of reporting the events were unresolved.
4-25-08 Mother called and stated child has a fine pinpoint red rash on trunk.  Has been fussy for 24 hours but worse the first 12 hours.  Advised to consult MD.  5-1-08 followed up with Mother.  She stated had taken child to MD on 4-25-08.  The rash had extended up to neck and cheeks.  It just went away on 4-28-08.  No fever.  They did blood test, one being a strept, which was negative.  They put the child on antibiotics (Keflex).  Stated they were checking her for Chorieformic movements because she also at the time of the rash developed "shimmy movements" like a cold chill twitch where she would knock herself over when sitting up.  To follow up with MD on 5-5-08. Follow-up Information 20-JUN-2008: The client saw a neurologist. The child continues with movements and the neurologist has told the parent that "too many vaccines at once triggered a resonse, not a reaction to a specific vaccine, but the amount of vaccines given." He has recommended that the child receive only one vaccine at a time in the future. I need to update that the client saw a neurologist. the child continues with movements and the neurologist has told the parent that " too many vaccinees at once triggered a response, not a reaction to a specfic vaccine, butthe amount of vaccines diven." He has recommeneded that the child recieve only one vaccine at a time in the future.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with a dose of GARDASIL. Subsequently, the patient developed swollen lymph nodes after one vaccination with GARDASIL. Nodes haven been swollen for more than one week. No further information is available.
She reported that she received AVA # 6 on 26 Jun in her left arm. Later that evening she developed pain and discomfort in her left shoulder with only mild  local redness and swelling around vaccination site. She reported that the pain and discomfort continues and reports improvement with ibuprofen and use of TENS unit. She stated she has been using cold and hot packs. She denied any previous history of shoulder problems and that the pain in her shoulder will wake her at night. She reports discomfort when she raises her arm and she denied any extensive swelling with her previous AVA but nothing this bad. She denied any other systemic symptoms. She stated that she believes both her and the vaccinator were standing during the immunization process. Pain in left shoulder.
Needle and base because unattached from syringe when pushing plunger in. Had to pull needle and base from patient's arm.
The patient described sudden onset of dizziness with visual disturbances, amplified photosensitivity, and double vision that occurred about 25 minutes after receiving the COVID19 (Moderna) vaccine. This lasted for about 20 minutes and then the visual effects subsided and she was able to drive. She reported that the dizziness did subsist for several hours at a low and tolerable level.
Nodular lesion on right thigh, 3 cm.  Treated with Benadryl and Tylenol.
This spontaneous report was received from a nurse concerning a 4 year old female patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On 13-NOV-2018, the patient received an additional dose of PROQUAD lot # R015746, expiry date: 02-DEC-2019 for prophylaxis instead of VARIVAX with sterile diluent (extra dose administered and wrong product administered). No adverse event was reported. No product quality complaint was involved.
Pt had Tdap injection about 9:30pm. Early morning pt woke with sweatiness, dizziness. Got up & passed out for short time.
The morning after 2nd dose of COVID 19 Moderna vaccination I felt nauseous and fainted. I passed out for about 2 minutes. In addition I had arm pain at site of injection and general fatigue.