chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horrible left arm pain/ pain is killing her/ it is super painful; she cannot sleep at night; The pain is located around the shoulder; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In June 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder). At the time of the report, PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that since patient had the 2 Moderna and one booster dose in Jun2022, she started to have horrible left arm pain. She initially thought that it would go away but it did not. The pain was killing her, it was super painful, was unbearable that she cannot sleep at night. Patient went to see her doctor but could not tell what was happening. They do not know if it coming from the muscles or the joints. The pain was located around the shoulder and the upper arm. She wants to know what was happening with her arm. Patient states that she knows a lot of people who have the same complaint - pain on the arm after getting the Moderna Covid-19 vaccine.   Treatment medications were not reported.
This case was reported by a consumer and described the occurrence of pain in a adult male patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included tendonitis (diagnosed 6 year ago). On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced pain and tendonitis exacerbated. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tendonitis exacerbated was unknown. The reporter considered the pain to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the tendonitis exacerbated to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. In 2016, the patient reported that he received a flu shot in his shoulder and he experienced 6 to 9 months of pain. The patient was diagnosed with tendonitis 6 years ago and he believed that the flu shot also aggravated his tendonitis condition. The patient had to disconnected and could not provide additional details.
PATIENT COMPLAINS OF RACING HEART, DIZZINESS THAT SHE CAN'T CONTROL AND HEAVINESS IN HER CHEST SINCE ADMINISTRATION OF THE VACCINE.  BLOOD PRESSURE AND PULSE ARE NORMAL AND THERE IS NO WHEEZING, LUNGS ARE CLEAR.
abdomen, upper extremities and head with multiple pustules; blister appearing spots/appears to be chicken pox; itch; This case was reported by a nurse via call center representative and described the occurrence of pustular rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date 1st December 2021) for prophylaxis.   On 13th July 2020, the patient received the 2nd dose of Shingrix. On 18th July 2020, 5 days after receiving Shingrix, the patient experienced pustular rash, blistery rash and itchy rash. On an unknown date, the outcome of the pustular rash, blistery rash and itchy rash were unknown.   It was unknown if the reporter considered the pustular rash, blistery rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The nurse reported patient received  her second dose of Shingrix and she had broken out on her abdomen, upper extremities and head with multiple pustules, what appears to be chicken pox.  They just itch, and had blister appearing spots. It started over past weekend and each day more appeared. The reporter did not think it was shingles. The patient did not experienced fever, malaise or anything else other than these breakouts. The reporter consented to follow up. This case has been linked with the case US2020138148 and US2020AMR138449, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138149:same reporter
As soon as I woke up in the morning I felt sick, my throat hurt my glands head and neck hurt, I had a severe headache body aches, chills, heat flashes more PVC then I normally have, weak and tired, super strong muscle pains, I took, motrin, xanax, flexxeril and alka selter sinus and chloraseptic for my throat pain , prn, I am due to have my 2nd booster shot today and I still have all the same symptoms but much milder now, but is seems to change constantly. I sure hope this next one causes no more side effects  and I will have immunity to this virus.
Breakthrough case admission after 4 vaccines Moderna 3/13/21 Lot# 001B21A;  Moderna 4/10/21 Lot# 037A21B;  Moderna 2/1/22 Lot# 016J21-2A;  Moderna 11/21/22 Lot# 062F22A
The pt came in the office to have a PPD site looked at. It is documented that a 6x7cm erythematous, warm, to the injection site. It started as splotches and then became a confluent area.
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 21:42, 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.
Red rash on upper torso/Rash behind knees/rash on waistline left and right of navel; rash was itching; the rash maybe hives; itchiness at the injection site; Tenderness in armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), AXILLARY PAIN (Tenderness in armpit), RASH ERYTHEMATOUS (Red rash on upper torso/Rash behind knees/rash on waistline left and right of navel), PRURITUS (rash was itching) and URTICARIA (the rash maybe hives) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced AXILLARY PAIN (Tenderness in armpit). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site). On 04-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on upper torso/Rash behind knees/rash on waistline left and right of navel), PRURITUS (rash was itching) and URTICARIA (the rash maybe hives). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), AXILLARY PAIN (Tenderness in armpit), RASH ERYTHEMATOUS (Red rash on upper torso/Rash behind knees/rash on waistline left and right of navel), PRURITUS (rash was itching) and URTICARIA (the rash maybe hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information for events included Benadryl (25 mg every 6 hours) and hydrocortisone cream.     Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.
Arm hurt really bad; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (felt sick) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 061E21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Hypertension and High cholesterol.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (felt sick). In 2021, ILLNESS (felt sick) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt really bad) 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.   No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-360000 (Patient Link).
Nausea, body aches, fever, lump on arm warm to touch and the size of a slice of Spam.
No adverse event; Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 mL booster of the Moderna Covid 19 vaccine instead of the full dose 0.50 mL).    No concomitant medications were reported. No treatment details were reported.
IM given in Right arm 3rd dose. (Booster). Pfizaer Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 @ 11:45 am. Given on 11/5/21 @ 11:45, out of time range. Patient contacted that evening. Pfizer manufacturer called. Patients called the following Monday letting them know that Pfizer was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/08/21 and let him know that Pfizer let us know the vaccine was viable, no additional booster vaccine is required.
Migraines everyday for a full week after; day after felt like all bones were broken, extremely painful to move; day after felt like all bones were broken, extremely painful to move; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced migraines every day for a full week after, day after felt like all bones were broken and extremely painful to move. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraines every day for a full week was resolved on an unknown date in Apr2021 and of the events felt like all bones were broken and extremely painful to move was resolved on an unknow date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pustule in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018 09:00, the patient received SHINGRIX. On 15th May 2018 17:00, 8 hrs after receiving SHINGRIX, the patient experienced injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning. On 16th May 2018, the outcome of the shivering, general body pain, injection site swelling, fever and injection site burning were recovered/resolved. On an unknown date, the outcome of the injection site pustule was recovered/resolved. It was unknown if the reporter considered the injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning to be related to SHINGRIX. Additional details were provided as follows: By 5 or 6 pm on the day of vaccination, the patient experienced pimples all around the injection site, burning at the injection site, shivering, chills, swelling at the injection site, low grade fever and body ache. The symptoms were lasted throughout the night. All her symptoms went away within the next day except the pimples at the injection site, they lasted 3 or 4 days.
HIGH FEVER, PNEUMONIA, SORE THROAT, PRODUCTIVE COUGH.  SYMPTOMS TOOK A WEEK TO SET IN AND IT IS FOUR WEEKS LATER WITH MILDER SYMPTOMS.  HOWEVER, IT IS CONTAGIOUS, SO WE HAVE THREE ILL FAMILY MEMBERS WITH ONE WITH SAME SYMPTOMS BUT WITH VARICELLA-ZOSTER RASH ONLY IN FOREARM.  DR. WOULD NOT GIVE FOLLOW UP CARE.
Patient presented to the pharmacy on the morning of 10/5/2019 stating she received a Shingrix shot on 10/03/2019 and her arm is numb. She stated her arm started to hurt on the evening of 10/04/2019 and at 1 am the next morning she put ice on it. She also tried a Epsom salt bath with little relief. Additionally, on the morning of 10/05/2019, she stated she could hardly move her right hand and it hurt to make a fist. Patient was asked if she had tried any other treatments other than the ones listed above and she replied no. The pharmacist visually inspected patient's right arm and no redness of rash was present. Patient felt wrist might be swollen, but no visible sign confirmed. Patient thought arm might be slightly warm, but patient reported no fever. Also, pt. reported exercising on 10/04/2019 in the pool using  buoys which she had been doing regularly. Pt. was advised to start Tylenol and continue with ice and monitor for changes and seek EMS if necessary. Pharmacy to follow up with patient.
pt recvd vax approx 7AM, noticed tired feeling approx 8 hrs later, fatigue x 2 days, better 3 days post immun, still tired; reported 20MAy93 130PM;
Minimal induration to left arm at 7 o'clock in relation to inj site, macular redness to left arm extending from injection site to left axilla. Tx: TAC cream, ice, TYLENOL PRN.
Chills, aches, low-grade fever, fatigue. Chills lasted 4 hours. Fever and fatigue 8 hours. Tremors for 4 hours.
Loss hearing 100% right ear. I received the 1st shingle shot went to sleep woke up in the middle of the night with a high fever took aspirin at 4:00 AM woke up at 10 AM with whistling and my ear went blank could not hear nothing called my doctor they told me to go to walk in clinic at pharmacy at 11:30 AM-she told me it was a reaction from the shingle shot that it will take a couple of days. I never got my hearing back. I have been back to my doctor on the 27th of July seen by MD was prescribed prednisone 10 mg tablets and was sent to Otolaryngology and have seen him several times since my last appointment was on 9-17-18 and I still have no hearing!!
Pain in all joints and muscles; Pain in all joints and muscles; Chills; low fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 11:45 (Lot number: Ff2589) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha, penicillin; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Sulpha, penicillin; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EW0198, Vaccine location: Right Arm , Administration time: 13:00), administration date: 30Aug2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 03Oct2021 05:00, outcome "unknown" and all described as "Pain in all joints and muscles"; CHILLS (non-serious) with onset 03Oct2021 05:00, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 03Oct2021 05:00, outcome "unknown", described as "low fever". Therapeutic measures were not taken as a result of arthralgia, myalgia, chills, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected...
TOOK ALL FOUR DOSES AT THE SAME TIME; This spontaneous case report was received from a pharmacist (PVX2019-533) on 27-Feb-2019. The report describes an adult consumer who "took all four doses at the same time". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took all the four doses of Vivotif at the same time.  The action taken with Vivotif with respect to the event "took all four doses at the same time" was not applicable.  The clinical outcome of the event "took all four doses at the same time" was unknown.  Company's Comment: The causality of the event "took all four doses at the same time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all four doses at the same time" was considered as not applicable.
Patient reported a scratchy throat with both doses of vaccine.  Patient disclosed this at the time of her 2nd dose.  Reaction occurred within approximately one to two minutes of receiving her dose.  She said she was having no difficulty in breathing and that she felt "normal" other than a scratchy throat.  Patient was offered Benadryl and declined.  Patient was given a cetirizine tablet and a cup of water and said she was feeling better within about 10 minutes.  She was also monitored for an extended time period.
tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expuiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient had no known underlying conditions. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient felt very tired after receiving the second dose of Pfizer COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.