chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flushing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing) and MYALGIA (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 027A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included UBIDECARENONE (COQ-10) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 FLUSHING (Flushing) and MYALGIA (Sore arm). At the time of the report, FLUSHING (Flushing) and MYALGIA (Sore arm) outcome was unknown.            No treatment medication was provided.   This case was linked to MOD-2021-374206, MOD-2021-374385 (Patient Link).
Started w/pain in the arm (left) immediately after the shot. Progressed to neck and Headache. Patient has had pain in the arm that the vaccine was given on for 4 month now. Patient takes tylenol & tramadol for pain. The pain causes a lot of discomfort and also decreased Range of motion
approx p/arm began to swell & get red & hot almost 6" days;the next am was swollen from top of  shoulder to the elbow, redness & hot spot inc in size;swollen past the elbow 2";hard spot on arm;
Swollen armpit under left arm, same side and being injected on left shoulder. Slight pain/discomfort
On my shoulder is badly affected. My shoulder, I have loss of you know; It affected my shoulder, I have pain in my shoulder; vaccine is interfere with the function of my shoulder.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Oct2021 (Lot number: 30135BA) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "To help prevent hair on my head from falling" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA taken for alopecia. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 13Sep2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "On my shoulder is badly affected. My shoulder, I have loss of you know; It affected my shoulder, I have pain in my shoulder"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "vaccine is interfere with the function of my shoulder.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, musculoskeletal discomfort.  Additional information: Any other vaccination: No, the patient didn't take any other sort of vaccine. The patient was going to Physiotherapist.  No follow-up attempts are possible. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 15-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 54-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 20-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Developed severe left breast pain had X-rays done thought pneumonia was on antibiotics went back for another X-rays  it was worse did contrast CTscan fluid on left lung had to have fluid taken out 720cc still no cause  and I still have tightness in lung
Started in the morning with some aches and chills, ans headache. Took ibuprofen  and felt better most of the afternoon. The symptoms returned mid-evening, with the addition of fever, joint and muscle pain, nausea and dizziness.
Narrative: Headache, Myalgia, Fever & Nausea Vomiting, Tenderness right axillary lymph nodes. Lymph nodes are swollen and "puffy"
At 9:00PM the day of vaccination I experienced very strong chills, fever, and achyness in my spine. It lasted until the next morning at about 7:30am when I took some ibuprofen.
I didn't have any immediate symptoms from the vaccine. In June I started to feel stiffness - in my legs - on the top of my thigh. At the joint between thigh and pelvic area. On both sides. I had a doctor visit. I had physical therapy after testing and getting diagnosed with arthritis. I had therapy for 10 visits. That didn't help with the symptoms. I also had an injection - it was a steroid injection and that made it worse. I am on physical therapy again now. I also had a cataract removed. That was removed 2 weeks ago on the right eye. That is recovering okay.
Rash and urticaria pruritus. Diphenhydramine, hydrocortisone.
Pain, muscle cramping and tenderness Right deltoid, Right bicep/tricep and forearm extensor muscles very tense, crampy for 10 days. No fever. No generalized muscle complaint.
Pt stated had increase of asthma and did not read the consent for the VIS that it was a contraindication to mist. Stated she developed "a little more congestion and for the last 2 wks experienced nausea and vomiting intermittently and was feeling a little under the weather". Has followed up with her MD. Encouraged her to contact him again regarding persistent symptoms.
The day following the injection I experienced swollen glands under my right arm that subsided after a few days.  1/4/22 I began with COVID symptoms and received a positive diagnosis 1/6/22. I was sick for the first quarter of the year with varying symptoms ranging from uncontrolled blood pressure to intermittent fever, dizziness/vertigo and incredible fatigue. I have also had an increase in fibrous cycsts in my breasts. My thyroid, which was previously controlled, also significantly changed during this time. I still struggle with symptoms daily.
received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 23-Dec-2020. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 17-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 17-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. There was no adverse event with this patient, the patient received her first Pfizer vaccine, patient never received a second vaccine, came into office requesting another vaccine our health center explained we only have Moderna, patient asked to receive Moderna. Health center did not question the request since it has been close to a year since receiving the first vaccine. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up information includes reporters details, patient demographics information, ethnicity, vaccine information and narrative was updated.
about 20 hours after vaccine I started getting covid symptoms -- which I understand is typical. The aches, pains. But in an instant my tongue got all tingly like your arm when it falls asleep -- and I lost my taste buds. It came back the next day when all the aches left as well.  I was diagnosed with covid a few months ago and am aware of the symptoms and lost my taste buds then as well.
Initial and follow information has been received form a registered nurse concerning a 6 month old patient who on an unspecified date was vaccinated with an adult dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) (reported as pneumonia vaccine). It was reported that the patient was taken to their pediatrician's office for routine immunizations when the event occurred. The reporter was unsure whether this was pneumococcal vaccine 23 polyvalent (manufacturer unknown). After arriving home that day, the child's parent was informed by a nurse at the pediatrician's office that the child was mistakenly given the wrong immunization and the wrong dose. It was reported that the child developed a slight fever the evening after the dose was given (temperature measurement not provided). Unspecified medical attention was sought. At the time of the report, the outcome of the fever was unknown. No further information is available.
sore,achy; allergic reaction; swollen glands; sore throat; fever up to 101F; face, ears, neck and chest turned bright red, very hot; face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish; nausea; Headache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 17Mar2021, as dose 2, 0.3 ml single, in left arm, for COVID-19 immunisation. The patient's medical history included unspecified allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as single dose in left arm for COVID-19 immunization. The patient's historical vaccine also included flu shot in Oct2020 and was bruised, the whole musculature from the shoulder to almost elbow, was very sore. The patient's past medication included Tetracycline take for unknown indication and experienced allergy. On 18Mar2021, 1 day after the second dose of vaccine, the patient experienced headache and nausea. On 19Mar2021, the patient experienced fever up to 101, her face, ears, neck and chest turned bright red, very hot to touch. Patient's ace, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and had allergic reactions. On an unspecified date after the second dose, the patient also experienced swollen glands, a little achy, sore and had sore throat. The patient underwent lab test and procedure which included body temperature: 101. The clinical outcome of event fever up to 101 was resolved on an unspecified date and event nausea was resolved on 20Mar2021. The clinical outcome of events headache, face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and event face, ears, neck and chest turned bright red, very hot was resolving. The clinical outcome of all other events was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.16    Concomitant products were not provided.  On 22-Jun-2021,, Excursion time was 08 AM, 10 AM temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-Myr-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 22-JUn-2021  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: 00.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported   This case was linked to MOD-2022-566976 (Patient Link).
Arm pain at injection site.  Redness, itching and swelling at injection site.  Pain when lifting or moving arm for 3 days.  Developed neck pain within 6 hours and gradually got worse during the night on the same side as the injection.  The pain moved to the other side of the neck (right side) a few days later.  The  neck pain has continued to reoccur on both sides of my neck since the second injection on 5/11/21, occasionally going away then coming back a day later.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, feeling bad and myalgia upper extremities. On an unknown date, the outcome of the fever, feeling bad and myalgia upper extremities were recovered/resolved. It was unknown if the reporter considered the fever, feeling bad and myalgia upper extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a mild fever, muscle pain down her whole arm and she felt bad for 5 days. This was 1 of 4 cases, reported by the same reporter.
Morning after vaccine, I did not feel good. Had sores in mouth, low grade fever all day, aches and pain all over with nausea and diarrhea. Lasted for about a whole week. I went to dentist for sores in mouth (was prescribed mouthwash). The diarrhea finally subsided. When I saw a doctor, he gave me mouth was for the sores in mouth as well.  The initial  feeling of me not feeling well lasted for a week, but the sores and diarrhea lasted a lot longer.
2nd day had a red hard spot at place of shot that was warm and tender to touch, it was about the size of the palm of my hand and got a little bigger the 3rd day. 2nd day I had diarrhea, I ached all over, and I was very tired. I ran a low grade fever and had chills. It is the 3rd day now, the area on my arm is still very red and itches a little and it is a little bigger than the 2nd day, (it is hard and warm), but I do not have diarrhea anymore. I have taken TYLENOL for the muscle aches.
Large erythema.  Right thigh, 6in area of in duration, mild discomfort
Pt got ZOSTAVAX on Thursday 11/2/17 - It hurts a little, Friday and Sat, she felt hurtful sensitive to touch at site on Injection, felt like a knot of skin swollen, light pale now but red, itchy on Friday. She showered this morning (Sunday), redness went down but itchy.
PT 7 MINS POST VACCINE BECAME DIAPHORETIC, A/Ox0, UNRESPONSIVE TO VERBAL STIMULI, EPISODE OF SYNCOPE LASTING LESS THAN 1 MINUTE. PT LAID ON FLOOR AND STERNAL RUB PERFORMED. PT RESPONSIVE TO PAINFUL STIMULI. V/S W/IN NORMAL LIMITS WITH SPO2 PRESENTING AT 93% BUT RESOLVED ONCE PT BECAME A/Ox3. PT GIVEN WATER TO SIP ON AND DISCHARGED IN NAD.
Got two doses of Gardasil and notes muscle pain and discomfort globally (not at site) at nite 3 wks after admin.
Symptoms of the following: Late PM of 4/17/2021 into early AM of 4/18/2021: Fever >100.4*F , body aches, muscle aches, chills, headache, fatigue.   4/18/2021:  Fever >100.4*F, body aches, muscle aches, chills, headache, fatigue, loss of appetite   4/19/2021:   Fever >100.4*F, body aches, muscle aches, chills,, fatigue, SLEPT ALL DAY and NIGHT, bad night sweats, loss of appetite.  Lower abdominal pain over my bladder and right lower abdomen  4/20/2021:  Fever >100.4*F, body aches, muscle aches, chills, headache, fatigue, slept a lot again, loss of appetite. Lower abdominal pain over my bladder and right lower abdomen. NEW COUGH, really bad night sweats and congestion. LOSS OF SMELL  4/21/2021:  Felt a bit better in the morning, but had a fever later and throughout the day, body aches, muscle aches, chills, headache, fatigue, COUGH, & LOSS OF SMELL.  4/22/2021: Feeling a bit better, no fever today. Had really bad night sweats, so bad I had to change my clothes and sheets because they were soaked, able to work again today. Still have a COUGH.    Also - my wife had her 2nd Moderna vaccine on 4/15/2021 and was ill on Friday.
Information has been received from a nurse in a physician's office concerning a female who was vaccinated with a dose of GARDASIL (lot # not reported). Subsequently the patient experienced a seizure after the vaccination. The patient was air lifted to an unspecified hospital and was admitted as an inpatient for unspecified amount of time. At the time of the report (23-FEB-2009), the patient was recovering. It was reported that the patient was not given the vaccine at this physician's office. The nurse learned of this adverse event through the grandmother of the patient. Additional information has been requested.
Rash through out all her body for 5 days. Treatment was benadryl and prednisolone.
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the event was unspecified. This event occurred in 7 patients. Linked cases include A0746425A, A0746426A, A0746427, A0746428A, A074629A and A0746430A. Follow-up identified a product complaint number. It was additional reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on November 2008 from GSK and stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse event were recorded."
Rotarix was injected instead of oral administration; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's comment: The physician asked for information about the wrong administration of Rotarix to the patient.  The reporter reported that Rotarix was injected instead of being administered via oral.  Since the physician was not at his office, and he was notified about this situation by a nurse. The reporter did not provide any data about the patient and the vaccine that was administered. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Rotarix lyophilized which was injected instead of being administered via oral, which led to inappropriate route of vaccination.