chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received his vaccinations on 1/21. He also received a penicillin G benzathin 600000U/ml (1.2 MU) IM injection that same day. On 1/22 he presented with stomach pain, nausea without vomiting, myalgias. He was given bismuth subsalicylate and acetaminophen.
HCP calling  to report a temperature excursion. Vaccine was administered after temperature excursion. No additional AEs. No PQCs.; HCP calling  to report a temperature excursion. Vaccine was administered after temperature excursion. No additional AEs. No PQCs.          ?    Names of vaccines involved (including lot/exp) VARIVAX; lot: W02294;  exp: 07/13/2024        ?    Temp; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JAN-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, administered for prophylaxis (dose, units, strength, lot #, expiry date, and route of administration were not provided). On an unknown date, HCP was calling to report a temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) with lot#W02294, expiration date: 13-JUL-2024. Before administration vaccine was storaged for 30 minutes in 7.1 degree Fahrenheit, 1 hour in 11.6 degree Fahrenheit and 15 minutes in 6.9 degree Fahrenheit, Vaccine was administered after temperature excursion. No additional AEs. No PQCs.   Related AEs 02367446, 02367491,02367497, 02367502, 02367511, 02367514 filed.  Lot #W02294 is not valid for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product.; Sender's Comments:  US-009507513-2304USA002102: US-009507513-2304USA002206: US-009507513-2304USA002245:
1 hour post vaccine administration, patient presented to HC with swelling, erythema and pruritus to orbital eye area bilaterally.  Patient was given an injection of 50mg IM Benadryl and cool compresses to area.
Extensive sweling of vaccinated limb; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. The age group was captured as adult as per Shingrix indication.  The caller reported a few patients had severe redness and swelling from shoulder to elbow. The caller provided limited information and declined to provide patient-specific information as they were not directly patients of his, only people who had called him asking for more information about reactions. The reporter did not consent to follow up.
Patient admitted to COVID floor on 8/25/21 for acute hypoxic respiratory failure secondary to bilateral pneumonia COVID-19. She was initiated on dexamethasone and remdesivir. Pulmonology consulted 8/31 for worsening hypoxemia, on heated high-flow nasal cannula and alternating with noninvasive positive pressure ventilation. On 09/02 patient was transferred to the COVID19 ICU for worsening respiratory status. Patient requested multiple times to delay intubation and maintain on AVAPS. She did have a feeding tube placed and was receiving tube feeds. She essentially became dependent on noninvasive ventilation unable to wean. She did attempt self proning with some improvement in her oxygenation. This morning, patient's oxygen saturations dropped to 60s with increased work of breathing despite noninvasive ventilation and self proning. Discussed with patient again and she was agreeable to being intubated and family agreed. Patient sedated and intubated, unfortunately shortly after intubation patient had a PEA arrest and Code Blue called. See previous note for details. Ultimately, after multiple rounds of CPR, epinephrine, defibrillations without persistent return of spontaneous circulation and approx 35 minutes resuscitation efforts, all resuscitation efforts stopped and time of death called at 08:07am.
Redness, swelling and hot to touch from shoulder to elbow. Tender to touch. Headache and stuffiness.  Did not seek treatment.  took Tylenol and applied ice
arm is really sore; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted). At the time of the report, PAIN IN EXTREMITY (arm is really sore) and FATIGUE (extremely exhausted) had not resolved.            no concomitant medications are provided. treatment to the events not reported.
Information has been received from a registered nurse concerning a 13 year old female with no pertinent medical history and no drug reactions or allergies who on 17-MAR-2007 was vaccinated IM into the left deltoid with Gardasil (Lot #655619/1427F). The nurse reported the patient was administered an incomplete dose of Gardasil and soon after fainted. The nurse also reported that while she was administering the patient's first dose of Gardasil she experienced some resistance in the plunger of the syringe. Before finishing the injection, some of the vaccine leaked out around the injection site. When the patient was informed of the problem and possibly of another injection she fainted. The patient fainted 3-5 minutes after the vaccine was administered. On 17-MAR-2007, she recovered quickly. The patient's vital signs were taken and she was monitored for twenty minutes. The office received an e-mail from the patient's father one hour after she left the office which stated that she had fully recovered. There were no laboratory diagnostic studies performed. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is expected.
Woke up with sore arm on my right arm and redness. It felt a little stiff. I also had a fiery headache. I took some Tylenol and put ice on my arm for the redness because the area also felt hot. I kept moving it and massaging it so the stiffness would go away. I rest some. The next day I felt much better.
Nausea with slight chills and sweating the next morning.  Fatigue and low energy with body aches for 12-16 hours after.
Case number PHEH2014US021291 is an initial spontaneous report from the health care professional received on 20 Oct 2014. This report refers to a 16-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 014021A) intramuscularly on 14 Oct 2014. No adverse event reported following this medication error.
Pt came in Monday 8/20/12 for 3 immunizations had MENACTRA in (R) arm, HPV & Tdap in (L) arm. Pt noticed swelling, redness, & slight pain 24 hours later. Dr gave pt prednisone.
Information has been received from a medical assistant concerning a female who was vaccinated with Gardasil vaccine. One day after she was given Gardasil vaccine, the patient's arm was swollen and she had a rash. The patient contacted her physician. Subsequently, the patient recovered from the arm swelling and rash. Additional information is not expected.
Information has been received from an "over sixty year old" female consumer with a history of allergy to pet dander, who on 10-JUN-2008 received a single 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously for the prevention of herpes zoster (lot # 659324/1835U). The patient reported that "about two and a half years ago" she experienced shingles on the side of her face after being administered ZOSTAVAX (Merck) on 10-JUN-2008 and that the rash spread into her left ear and left eye. The patient said she got the injection because her physician had "told her to do so". The physician did not perform a titer test on the patient to see if she had a history of chickenpox. The patient "regrets getting the vaccination and got it out of fear of getting shingles". The patient sought medical attention (not specified) and at the time of reporting did not yet recover. Additional information has been requested.
Itchy blisters covering entire body, was prescribed Prednisone by healthcare provider. Used ultra violet ray machine on patient, blistering became worse.  Dermatologist.
Tired for two days following vaccine, large red mark on arm, itching on arm. A week later fairly severe lymph node swelling under arm of the arm that had the vaccine shot. This lasted for three days.
Employee received the H1N1 injection. Returned immediately to work and was involved in a pt code. Performed chest compressions for 10 min., later felt pain at injection site. Arm continued to feel "heavy with tingling from elbow to hand". Eval. on 11/4/09 after reporting above. S/S are subsiding, will follow up with neuro if not resolved by 11/6/09.
Fever; Chills; Body ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) 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 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Chills, fever 99.9 while on fever reducers, headache, fatigue, possible throat tightness, sore throat, red eyes.
Patient became dizzy immediately after administration of MENACTRA. Patient had a brief period of syncope and incoherence while sitting on the table. Vital signs monitored for 20 min & ammonium inhalant utilized with prompt recovery of the patient.
Severe rash, chills, headache, itching, burning. Still causing inflammation and lesions 11-28-17 thru 12-22-17.
Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour; Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that; Developed headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 026D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-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 PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache). At the time of the report, PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-355883 (Patient Link).
From physician note:  "her right arm shows an inflammation, some redness and mild induration at the site of her recent injection when she got her pneumonia shot at discharge last time".  Mild reaction to the right arm.  Patient currently receiving antibiotic therapy due to possible diverticulitis, recovering pneumonia.
Osteoarthritis of the right hip, Naproxene (500 MG) for 2 weeks , then X-ray guided needle injection of hip Neither has done anything to reduce the pain and allow unrestricted movement.
After my Moderna first dose vaccine, I developed a rash on my chest which radiated to my torso and down to my upper thighs. The ras was very itchy upon palpation and I also had raised bumps that were large. My husband went to buy me Benadryl which I took but it did not work for me. I went to see my PCP and he prescribed me Prednisone medication which did help to relieve the itchiness and raised bumps go away.
PATIENT FELT VERY NAUSEATED, AND PASSED OUT FOR 20 TO 30 SECONDS BEFORE BEING CONSCIOUS. HE SAID AS A CHILD HE WAS CHASED AROUND WITH NEEDLES AND HE IS VERY AFRAID OF NEEDLES. AFTER FEW MINUTES HE WAS COMPLETELY FINE AND HE WALKED OUT OF THE PHARMACY ON HIS OWN.
achy; muscle pain / could hardly move without it hurting; fatigue; Back ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 (Lot number: FC3182) at the age of 84 years as booster, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL9261, LEFT ARM), administration date: 24Jan2021; Bnt162b2 (Dose 2, Lot: EN6200, LEFT ARM), administration date: 22Feb2021. The following information was reported: PAIN (non-serious) with onset 23Sep2021, outcome "recovering", described as "achy"; MYALGIA (non-serious) with onset 23Sep2021, outcome "recovering", described as "muscle pain / could hardly move without it hurting"; FATIGUE (non-serious) with onset 23Sep2021, outcome "recovering", described as "fatigue"; BACK PAIN (non-serious) with onset 23Sep2021, outcome "recovering", described as "Back ache". Additional information: Time the Vaccination Was Given: AROUND NOON. The Vaccination Facility Type was Pharmacy. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US022361, is an initial spontaneous report from a nurse received on 29 Oct 2015. This report refers to a 54 years old female patient. Medical history and concomitant medications were not reported. The patient received 0.5 ml of FLUVIRIN (batch number: 1515101) via subcutaneous route of 21 Oct 2015. On the same day after vaccination the patient experienced injection site reaction. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Patient stated that she had hives 20 minutes after receiving  the vaccine. She proceeded to take a antihistamine (zyrtec) and the hives went away. Patient stated she was feeling okay after about an hour.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second doses of GARDASIL (lot number, expiry date, route and site not reported) on 16-FEB-2011 and 14-MAR-2013 respectively. No adverse symptoms reported. The outcome was unknown. The same event of the twin of the patient was captured in MARRS # 1303USA010070. Additional information has been requested.
Patient's mother called in that patient "was covered head to toe in hives.  The family called his Dr. who put him on Medrol dose pak".
Swollen at injection site (size of softball), red and rash-like. recommended patient wrap area to keep clean and seek treatment if worsens.
Patient presenting with complaints of throat itch. Provider assessed patient noted no angioedema, no airway compromise. Patient given 25 mg Benadryl PO. Patient left feeling symptoms improved itch resolved.
Felt asthmatic; Inflammation inside the throat; Sore arm immediately after receiving the first dose of moderna vaccine; A little sweating immediately after receiving the first dose of moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHMA (Felt asthmatic), HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine), THROAT IRRITATION (Inflammation inside the throat) and LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine) and LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine). On 07-Jan-2021, the patient experienced ASTHMA (Felt asthmatic) and THROAT IRRITATION (Inflammation inside the throat). On 06-Jan-2021, HYPERHIDROSIS (A little sweating immediately after receiving the first dose of moderna vaccine) had resolved, LIMB DISCOMFORT (Sore arm immediately after receiving the first dose of moderna vaccine) outcome was unknown. At the time of the report, ASTHMA (Felt asthmatic) and THROAT IRRITATION (Inflammation inside the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Inhaler. No concomitant medications were provided by reporter.   Reporter did not allow further contact; Sender's Comments: This case concerns an adult female with a nonserious unexpected event of asthma, hyperhidrosis, throat irritation and expected limb discomfort. Event onset 2 days after first dose mRNA-1273. Treated with prednisone. Event outcomes unknown. 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.
Immune response began within 2 hours (Covid survivor.)  Resting heart rate increased to 96bpm and stayed there for a month. Increase in palpitations noticed  during workouts and continues to present while working out.
Broken nose; Rib fracture; Body ache; everything turned cloudy; A report from was received from a 66 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced everything turned cloudy, and his car crashed, suffered a broken nose, rib fracture and body ache.  Patient's medical history and concomitant medications were not reported.    On 24-Feb-2021 the patient received his second dose of mRNA-1273 (Lot number: 012L20A) injection intramuscularly in his left arm for prophylaxis of COVID-19 infection. On 25-Feb-2021, the patient crashed into a fire truck while driving. The patient "totalled" his Feb-2021, the patient was home with body aching everywhere  The events broken nose and rib fracture and  were medically significant.  Action taken with mRNA-1273 was not applicable.  Patient was treated with Ultram (tramadol hcl) 50mg and Skelaxin (metaxalone) 800 mg.  Outcome for the event of body ache was not recovered/not resolved and for all other events the outcome was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Nurse administered too much vaccine.  Contacted patient and told  to notify clinic  if any significantly worsening symptoms.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-NOV-2012 14:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Infant received immunations early in the AM 5/8/2007 and by that PM was having inconsolable crying that persisted for >72 hours without any resolution.  She also experience fevers to 101.7 F for 72 hours.
Within minutes of getting the shot I blacked out for about 3 or 4 minutes. I came to and threw up. My vitals were monitored in the back of an ambulance, where my heart rate and blood pressure dropped abnormally low over and over again. At first it happened in close intervals with more dangerous drops in rates, but slowly the episodes started to spread out. My heart rate and blood pressure continued to drop periodically for 9 hours before stabilizing. I also experienced unprecedented and unwarranted panic attacks for several weeks afterwards and have my blood pressure has not been the same as it was prior to the vaccine.
Patient called pharmacy 4/14 stating that she experienced nausea, persistent fatigue when walking, and hyperphoresis the day of and the day after the immunization on 3/29.