chrisvoncsefalvay/vaers-outcomes huggingface dataset:
45 year old patient received shingrix; Headache; Tiredness; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 45-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 2nd July 2020, the patient received the 2nd dose of Shingrix. On 2nd July 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness and low grade fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the headache, tiredness, low grade fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the headache, tiredness and low grade fever to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine in left arm and experienced headache, tiredness and low grade fever. The patient received vacine at age of 45 years old which was not recommended age for shingrix vaccine administration and led to inappropriate age at vaccine administration. The reporter asked if the shingrix injection was a live vaccine and whether it would effect his six month old baby and received reply as shingrix was not a live vaccine. The reporter did not consent to follow up.
Patient began having nausea, itching and tachycardia approximately 15 min after injection.  Symptoms progressed to feeling of tightness of the throat, diaphoresis, swelling of the eyelids and worsening nausea and itching.
Pt received vaccine 6/25/14, PMP LMP 6/10/2014 and Hcg 7/28/14; pt had stopped OCs "after last period"; received GARDASIL at potentially fertile time; pt unaware of potential for effect.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     In was unknown if the patient ever been diagnosed with/tested positive for Covid-19.  Acute illness at the time of vaccination and up to one month before was unknown.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient age was reported as 68 years and 9 months On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Vaccine NDC code was reported as 80777-0273-99. No treatment medication was provided.
It has been 17 days since being immunized and patient states she is still experiencing soreness and limited range in mobility in her left arm. She states she is unable to raise her left arm above her head and unable to move her arm too far backwards.
I ended with COVID after the 1st dosage and then when I received the 2nd dosage of the vaccine my arm was swollen and it went from purple to red (took a picture of it). I couldn't feel my arms and legs. My husband helped me get off the couch because I couldn't move and he helped me to go to be bathroom. I took a Tylenol afterwards and it didn't work; therefore, I became afraid that I was losing lymph nodes in my arms and legs. My doctor ran some blood tests for blood clots. I was referred to a Cardiologist for difficulty breathing and the tests were performed. He referred me to a Lung Specialist for further testing. I have to wear a monitor for 24-hours to monitor my oxygen levels (awaiting call back to be scheduled).
This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter.
Patient had a vasovagal reaction within 5 minutes of receiving vaccine.  She was given water to drink and an ice pack on the back of her neck.  She recovered quickly to normal respiration, pulse and skin color.  She left with her mother after additional time in the observation area.
Tired; Pain in arm/ arm hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/ arm hurt a lot) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/ arm hurt a lot). On 18-Mar-2021, the patient experienced FATIGUE (Tired). On 19-Mar-2021, PAIN IN EXTREMITY (Pain in arm/ arm hurt a lot) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Tinnitus in Right ear has gotten worse. Ringing and buzzing sound is louder. Higher pitched voices and sounds are echoing in right ear. It started in the afternoon on March 18th and is still continuing today March 22.
Immediate feeling of tahycardia, numbness in feet and feeling of passing out after injection.  My immunologist believes that this was a cytokine storm reaction (non anyphylaxis).  Store gave me water and cookie to help.  Discomfort continued.  Paramedics were on site and did work up on me and allowed me after 1 hour to go home where fever and chills continued for 2 hours.  Immunologist would like to administer second dose in her office using desensitizing approach.
Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection.  Feeling flushed with the first 15 minutes after injection.   Soreness at injection site 24-48 hours after injection.
Arm soreness that was  mild went away after the shot.  Then the "weird" or uncomfortable soreness that feels to her like cold nerve pain or just super mild discomfort did not go away completely and has still not gone away so far 5 days after the vaccine.. Patient also leg discomfort (super mild but also not totally normal) for 1-2 days after the vaccine. She is not sure if the neck moderate pain  that radiates to the back is associated and it started on Tuesday or 4-5 days after the vaccine. Like a cold numbness is how she would describe it.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 15-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient developed lightheadedness, shortness of breath, and pruritus about 15 minutes post-vaccine @ 0835. Patient was treated with Epi-pen x1 dose @ 0840 and Benadryl 25mg po @ 0842 for diffuse pruritus. She then reported continued shortness of breath, with new symptom of subjective throat and lip swelling and pruritus. A second dose of epinephrine via Epi-pen administered at 0850 followed by second dose of Benadryl 25mg po at 0852. Pt was transported to ED for further evaluation and treatment and received a third dose of epinephrine en route to the hospital while in ambulance (time unknown). In the ED, she was treated with Ativan 1mg IV. After observation for several hours in the ED, she was discharged home from ED to home care. Symptoms resolved later that day. She had no residual symptoms the day following vaccination, 14 Jan 2021.
Initial misuse report received from a healthcare professional on 24 June 2013. A child who had received MENACTRA couple of months ago was given another vaccine. No adverse event was reported. Documents held by sender: None.
improperly stored administered doses of PNEUMOVAX 23; No reported adverse affected; Information has been received from a health care worker referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.   On 20-MAY-2019, the patient was administered an improperly stored dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, with lot number R018136 and expiration date on 10-JUL-2020 (strength, dose, dose number and anatomical injection site were not reported) for prophylaxis.   It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 degrees Fahrenheit (F) (49 degrees F) for 171 (units not reported). There was a previous temperature excursion reported. The call was not placed because of a Digital Data logger report. No reported adverse affected.; Sender's Comments:  US-009507513-1905USA012688:
Immediately face and neck became very itchy but no rash and then was gone by the next morning. But then extreme pain the following day under left armpit. Could not hold even a sock or move without causing more pain.  I was in tears and as time went on I became in more pain. It was swollen under my arm pit and I was shaking from the level of pain. Left arm was also tingly. I called a nurse and they told me to go to the er. they physically examined me and told me the lymph nodes were swollen. To take Motrin and to come back if my arm be an to swell. The pain has decreased to be moderate/mild. I have more movement and can lift more weight now. It is still very swollen though.
Information has been received from a nurse practitioner concerning a 23 year old female with drug allergy to amoxicillin, prednisone, CEFTIN, BIAXIN and no pertinent medical history who on 18-NOV-2011 was vaccinated with the first dose of GARDASIL, intramuscularly (dose not reported) (lot number 669794/1285AA). On 22-NOV-2011 the patient developed fever (103 F), cough, body aches, neck pain and nausea after the first dose of GARDASIL was given. The patient sought medical attention by office visit to the nurse practitioner. There was no treatment for the event. No laboratories were performed. At the time of the report the patient had not recovered. Follow-up information has been received from a nurse practitioner who reported that the female patient with no illness at time of vaccination, allergy to amoxicillin, prednisone, CEFTIN, BIAXIN, CECLOR and a medical history of pneumonia as an infant was vaccinated with the first dose of GARDASIL, (dose not reported) (lot number 669794/1285AA) Right Arm at 14:35. The nurse reported that on 22-NOV-2011, the patient experienced neck pain, body temperature measurement of 103 degrees F, headache, cough, starting 24 hours after receiving GARDASIL dose. The nurse mentioned that the patient was on an emergency room and was exposed to meningitis in the past month, subsequently the patient was diagnosed with meningitis and pneumonia and also required hospitalization per 6 days. A diagnostic laboratory test was performed which resulted in meningitis. On unknown day of December 2011 the patient recovered of meningitis and pneumonia. The reporter felt that meningitis and pneumonia were not related to GARDASIL. Additional information is expected.
2PM pt started screaming @ 5PM lt leg red 7 swollen & t102.5, lt leg red & swollen from hip to knee;
p/vax pt devel fever & inj site rxn by erythema; swelling & pain; tx ATB
same day of vax pt devel hives on trunk & arms. treated w/benadryl
I was given 1mL of the vaccine instead of the 0.5mL. No adverse reactioNs.
Low fever; Extreme fatigue; Nausea; Couldn´t raise her arms/could only move her arms from the elbows down; Lost of appetite for a week or maybe more; Hives at the injection site; Severe pain in both soulders; Severe pain in neck; This spontaneous case was reported by an occupational therapist and describes the occurrence of NECK PAIN (Severe pain in neck), HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), ARTHRALGIA (Severe pain in both soulders) and PYREXIA (Low fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE for Antihistamine therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders). On 07-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site). On an unknown date, the patient experienced HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), PYREXIA (Low fever), FATIGUE (Extreme fatigue) and NAUSEA (Nausea). On 02-Jan-2021, NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders) had resolved. At the time of the report, HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), PYREXIA (Low fever), FATIGUE (Extreme fatigue), NAUSEA (Nausea) and VACCINATION SITE URTICARIA (Hives at the injection site) outcome was unknown and DECREASED APPETITE (Lost of appetite for a week or maybe more) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Concomitant medication included medication for birth control. It was reported that the patent experienced loss of appetite for a week or maybe more. Treatment information was not provided.   This case was linked to MOD-2022-466753, MOD-2022-466777 (Patient Link).
Patient complaining of headache, dizziness, fatigue, 10/10 right arm pain. Patient here to see provider in regards to vaccine given yesterday 10/17/23. Ibuprofen ordered for pain control. Patient has a follow up appointment in 1 week to follow up. Patient instructed to come see the provider if not any better or if pain get worse. If any signs or symptoms of infection noted.
Severe malaise; body aches with main pain in joints sever enough; body aches with main pain in joints sever enough; weakness; barely able to walk; unable to eat; bedridden for day; headache with severely exhaustion; foggy brained; fever 102.4; swollen glands in next armpits and general body swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Severe malaise), PAIN (body aches with main pain in joints sever enough), ARTHRALGIA (body aches with main pain in joints sever enough), ASTHENIA (weakness) and GAIT INABILITY (barely able to walk) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID infected with follow on pneumonia) from 22-Dec-2020 to 04-Jan-2021.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MALAISE (Severe malaise), PAIN (body aches with main pain in joints sever enough), PYREXIA (fever 102.4), LYMPHADENOPATHY (swollen glands in next armpits and general body swelling) and HEADACHE (headache). 30-Jul-2021, the patient experienced ARTHRALGIA (body aches with main pain in joints sever enough), ASTHENIA (weakness), GAIT INABILITY (barely able to walk), FEEDING DISORDER (unable to eat), BEDRIDDEN (bedridden for day), FATIGUE (headache with severely exhaustion) and FEELING ABNORMAL (foggy brained). The patient was treated with PARACETAMOL (TYLENOL) for General body pain and Joint pain, at an unspecified dose and frequency and CODEINE for General body pain and Joint pain, at an unspecified dose and frequency. On 30-Jul-2021, MALAISE (Severe malaise), ASTHENIA (weakness), GAIT INABILITY (barely able to walk), FEEDING DISORDER (unable to eat), BEDRIDDEN (bedridden for day) and PYREXIA (fever 102.4) had resolved. On 31-Jul-2021, PAIN (body aches with main pain in joints sever enough) and ARTHRALGIA (body aches with main pain in joints sever enough) had resolved. On 02-Aug-2021, FATIGUE (headache with severely exhaustion), FEELING ABNORMAL (foggy brained) and HEADACHE (headache) had resolved. On 05-Aug-2021, LYMPHADENOPATHY (swollen glands in next armpits and general body swelling) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood immunoglobulin G (Unknown-<1.44): 7.44 (High) High and high (High) High. On 23-Jul-2021, Blood immunoglobulin G (Unknown-<1.44): 3.80 (High) High. On 30-Jul-2021, Body temperature: high (High) 102.4. On 30-Jul-2021, Heart rate irregular: abnormal (abnormal) irregular.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.  On 30 Jul 2021 patient had irregular heartbeat.
This spontaneous report as received from a physician refers to a  patient of unknown age and gender. On 18-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
7/9/21 PMH of DM II, autoimmune cholangitis, essential HTN. Chief complaint AMS
Pfizer vaccine is used as a booster after my J&J vaccine last  November. I had pain at injection site and fever. I had pfizer vaccine on November2, 2022.  I am healthcare professional. I am supposed to give the shots to people on November 16 but I still tested positive so I did not go.  On November 6. I have high fever and headache all night. Runny nose and start coughing, sore throat and sneezing. Then, I checked rapid test. It turns out that I tested positive for Covid -19.  Then, I went for PCR test. It is positive.  I have those symptoms. I  took Andrographis and Augmentin. A few days later, I felt much better with less coughing and no runny nose. My sore throat went away after 5 days. I had fever only on the night of November  6. I still tested positive with rapid test until 11/15/2022.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with a dose of improperly stored ROTATEQ, orally, (dose and frequency were not reported), lot number K007247, expiration date 17-MAR-2016, 10 doses, lot number K023537, expiration date 22-JUN-2016, 10 doses and lot number K016263, expiration date 26-JUN-2016 25 doses. No adverse effects were reported. There was no concomitant medication reported. This is one of two reports from the same reporter (case # 1601USA002504). Additional information has been requested.
At about 1330 on 30DEC, the patient received the 1st dose of the Moderna COVID-19 vaccine.  Less than five minutes after the vaccine was administered, the patient noticed a metallic taste.  About two to three minutes afterwards, the patient noticed a ?tingling? sensation mostly on the left side of the face and minimally on the right side.  Almost immediately after the ?tingling? sensation, the patient felt the sensation of an increased heart rate and checked his pulse with his watch that had a pulse sensor.  The watch indicated that he had a heart rate of 115 bpm.  This sensation of an increased heart rate subsided after for one or two minutes and repeat pulse measurement was in the low 90s.  Towards the end of the 15 minute post-vaccination observation period, the medical technician did the final check on the patient.  The patient admitted to experiencing a metallic taste and a mild tingling sensation on the neck and face area.  The service member was immediately brought back to the treatment room were a faint red rash and was noticed on the left side of the neck by the medical providers present.  Two doses of Benadryl 25mg were given and the patient was told to continue to be observed in the observation area.  After about 20 minutes, the tingling sensation resolved.  The patient checked his pulse again and it was in the low 70s.  The metallic taste resolved after about one and a half hours after the start of the symptom.