chrisvoncsefalvay/vaers-outcomes huggingface dataset:
\itching in different body parts\head itched; Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (\itching in different body parts\head itched) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome (Causes dry mouth and dry eyes suffering for more than 20 years), Fibromyalgia (for more than 20 years along with Sjogren Syndrome), Diabetes, Thyroid disorder and Asthma.    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021). On 21-Sep-2021, the patient experienced PRURITUS (\itching in different body parts\head itched). On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) had resolved. At the time of the report, PRURITUS (\itching in different body parts\head itched) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypersensitivity: negativen (Negative) negative.         Concomitant medications include medicines for thyroid, diabetes, asthma and head. Treatment information includes intake of steroids for hives.
Patient was given Dose 1 of the moderna COVID-19 vaccine on 3/16/21 and admitted to the hospital on 3/31/21 with COVID-19
swelling and neuropathic pain in the left brachial plexus beginning within 2 days of vaccine.  she also has a residual sensory neuropathy in the C5 nerve root distribution on the opposite side that occurred after the second dose in the series.
Same day post vax, the pt developed a rash. Child has classical target lesions on his abdomen, back, and torso. Mom states rash is worse today. Rash also noted sparsely on arms and legs. Being treated with Benadryl.
only the liquid portion of Pentacel with no reported adverse event; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797).  This case is linked to case 2021SA110128 (same reporter).  This case involves a seven months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 25-Mar-2021 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none.    At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a medical assistant of physician via company representative refers to a 12 month old infant (gender unspecified). This case is referring one infant out of the twins who developed a red lump at the injection site after administration of VARIVAX (Merck). Patients medical history, drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with VARIVAX (Merck) Subcutaneous Injection, (lot number: J006732, expiry date: 30-MAY-2015), 0.5 ml, subcutaneous in the right thigh for vaccination. Concomitant therapy reported as none. The medical assistant reported 12 month old infant developed a red lump at the injection site after administration of VARIVAX (Merck). The infant was evaluated at a urgent care facility and were diagnosed with a local reaction from the vaccine. The patients are scheduled to be evaluated by the physician on 13-FEB-2014. No treatment was given for the event. No lab diagnostic studies were performed. No product quality complaint was involved. The outcome of the event was unknown. The reporters causality assessment for the event local reaction from the vaccine with the therapy of VARIVAX (Merck) was not reported. No further information provided. This case is linked with case 1402USA007653 as sibling report. Additional information has been requested.
Patient began complaining of visual disturbances and felt as though his house (specifically ceiling) was shaking. This happened on two occasions. Patient's blood pressure was consistently elevated e.g., ( 207/107), despite being on medication for HTN.  Ultimately on 4/21/21, patient was admitted to the hospital due to right sided facial drooping/weakness and slurred speech. Patient was diagnosed with a T.I.A. Treatment was obtained and patient was discharged from hospital on 4/22/21.
15min post vax pt collapsed then came to;given o2 & noted to be in atrial fibrillation;pt transferred to hosp 430PM then converted to sinus rhythm;pulse rate remained above 120-130;28JUN98 pt collapsed again;HR <40;resuscitation initiated
Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Vicadan).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Patient demographics updated and other relevant history 'Allergy to Vicadan' added
enlarged lymph node in armpit of the side the injection was on; uncomfortable; uneasy to keep her arm down; This is a spontaneous report from a contactable other healthcare professional (hcp). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ELI284, expiry date not reported), intramuscular on 29Dec2020 07:30 at a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Patient had no COVID prior vaccination and had no known allergies. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. Patient was just reporting symptoms experienced outside of normal symptoms that she was aware of: enlarged lymph node in armpit of the side the injection was on that began swelling about 7-10 days post vaccine and subsided after two days (Jan2021). Swelling of armpit lymph node was very uncomfortable and uneasy to keep her arm down. Again, went away after two consecutive days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the event "enlarged lymph node in armpit of the side the injection", uneasy to keep her arm down, and uncomfortable was recovered in Jan2021.
No appetite; No energy; Wiped out; A spontaneous report was received from a consumer concerning, a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events no appetite, wiped out and no energy.  The patient's medical history included cholesterol and macular degeneration. Products known to have been used by the patient, within two weeks prior to the event, included simvastatin, multivitamin, vitamin D and vitamins for eye.   On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the events no appetite, wiped out and no energy. Treatment for the events included paracetamol and acetaminophen  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of events, no appetite, wiped out and no energy was unknown at the time of this report.; Sender's Comments: Very limited information regarding this events has been provided at this time.Company assessed the events to be unlikely related to company product.
PATIENT RECEIVED  VACCINE- SAT FOR AWHILE THEN WALKED AROUND WITH HER HUSBAND IN THE STORE; PATIENT PASSED OUT; 911 WAS CALLED; PT REGAINED CONSCIOUSNESS WITHIN 1 MINUTE; WATER AND GLUCOSE TABLETS GIVEN.  BLOOD PRESSURE AND  PULSE OX CHECKED.  NO PROBLEMS BREATING. PARAMEDICS FURTHER CHECKED PATIENT AND RELEASED WITHOUT ANY FURTHER TREATMENT.  PATIENT REPORTS SEVERE MEDICAL PHOBIAS AND HISTORY OF SIMILAR REACTIONS
extensive pitting edema of arm from shoulder to wrist, erythema around inj site;edema gradually resolved spontaneously p/vax 1 1/2wk;no residual sequelae;no specific tx required
Severe body aches, leg cramps, fever, fatigue.  2-3? swollen, red, warm to touch area at the injection site.  Tingling in the left arm.
Large, red bulge near the injection site; Large, red bulge near the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site mass (received 1st dose on unknown date and developed  large, red bulge near the injection site, about 2 inches).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site mass and injection site erythema. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the injection site mass and injection site erythema were unknown.   It was unknown if the reporter considered the injection site mass and injection site erythema to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a large, red bulge near the injection site, about 2 inches after administration of 2nd dose of vaccine. The reporter consented to follow up. This case has been linked with US2020039257, reported by same reporter.
Left arm swelled 4x6 inch. Associated with fever, chilled for 4 days. Arm now better and fever now gone.
Patient checked in to facility on 10/14/2022 requesting bivalent Pfizer vaccine. The Medical Assistant took out the monovalent Pfizer vaccine from the fridge. Doctor did not visually inspect the vial and administered the Monovalent Pfizer Vaccine to the patient. Patient has not has any adverse symptoms that has been notified.
Arm pain  - day of vaccination Extreme Dizziness - 3 days after vaccination
pt rcvd vax; t 102 x 48 / dpt; decrease of appetite; loose stools; 1 & 1/2 warm red & bruised area at inject site;
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl,  1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
Injection site reaction; 14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose; Sick after second covid vaccine; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills), PYREXIA (Low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose). In October 2021, the patient experienced IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction). In October 2021, IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, INJECTION SITE REACTION (Injection site reaction) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the events of SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in Oct 2021, SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in Oct 2021 and SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in October 2021 was not provided. The reporter's causality for the event of INJECTION SITE REACTION with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Reports he noticed symptoms of extreme weakness a week after getting vaccine that he says persists today when he decided to call and report the problem.  He said along with continued weakness he experiences muscular pain when lifting that he never experienced prior to getting the vaccine.
About 4 hours after vaccine developed severe myalgia, chills, for about 2 hours I was incapacitated, took ALEVE, and felt better by 9 pm that evening. Since the vaccine I have developed severe ringing of the ears, and severe bil knee pain, and weakness of lower ext w extreme exercise, like not being able to lift my legs up.
Received 0.3 mL instead of 0.5 mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.3 mL instead of 0.5 mL) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Zoloft). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 25-Jun-2020 to an unknown date for Postpartum state.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 ml. On 23-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.3 mL instead of 0.5 mL). On 23-Apr-2021, ACCIDENTAL UNDERDOSE (Received 0.3 mL instead of 0.5 mL) had resolved. Not Provided          No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-090607 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021 included patient demographics, medical history, dose 1 and 2 details and concomitant medications added.
retinal issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-JUN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced retinal issues. On an unspecified date, the patient was treated by a healthcare provider for retinal issues. The outcome of the event retinal issues was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. In 2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # L046884 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event. Sender's Comments: US-009507513-1709USA002168: Original Case: 1709USA002093.
My right arm was sore and I had difficulty lifting it consistently until 48 hrs later. 12 hours later I had soreness in my right leg and my shoulder and upper back on the right, as well as a side stitch in my right side. I had slight redness at injection site until 48 hrs later.. At 24 hours later, I noticed some 2-3 painful lumps on the back of my head at the base of my skull in my hair, they felt like they were bruises but they had no redness or marks, warmth to touch, or itchiness/irritation. They were mostly sensitive to touch but ached slightly on the Monday (29th) following the injection. On Tuesday and most of Wednesday the lumps were still apparent but were not tender to the touch. On Wednesday night the lumps started throbbing and became much more sensitive to touch again. I couldn't lay on my back to sleep and even bending my neck a bit to sleep on my side made them throb intensely. I was unable to sleep much at all. I took ibuprofen to help the pain and it didn't help. Upon waking Thursday they were throbbing quite intensely and I was beginning to have muscular spasms in my scalp on the back of my head - which is also for me an anxiety reaction, which I was also feeling. I didn't have a headache per se, but the back of my head hurt. If I applied any pressure to the back of my neck on the right I had intense shooting pains from the neck up to the lumps on my skull. I do have pinched nerves in my neck but I have never experienced any pain like that before in that part of my neck nor into my skull. It was very sharp. On Friday morning the neck shooting pains subsided but the lumps remain painful to touch.
On 02/16/2023 I started having a sore throat runny nose, high temperature, and very tired. After reaching out to my health care provider and testing positive for Covid-19 I was prescribed PAXLOVID. Symptoms lasted 5 days.
3x4inch round red bump left arm.  Prescribed Zyrtec 1 tsp two times a day.  Patient had already had DTAP #4 on 09/19/2002).
Patient came in for vaccine was given vaccine by staff, pt seemed fine, about 10 minutes later pt and husband come back to the consultation window pt is in a wheelchair which she wasn't before and husband stated pt had fainted. We asked if she was okay, if she needed anything or if we needed to call ems. Husband states she is fine and looks at pt she said she was fine and while we were confiming she didn't need anything pt was passing out again. We gave her a bottled water, a wet paper towel and called 911. Once ems arrived they checked her out, asked her if she wanted help getting to the car and her husband to take  her home when she started gasping for air so ems took her on the hospital.
headache 1/18/19 - 1/19/19 R arm pain 1/16/19 - Still present Urgent care 7/21/19 injection of antiinflammatory PCP 7/22/19 FU Appointment 2/1/2019
This spontaneous case reported by an other caregiver, describes the occurrence of rash and insomnia (could not sleep) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A and 041B21A) for COVID-19 immunization. No medical history reported. On Apr 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. May 2021, patient experienced rash. On an unknown date, patient experienced insomnia (could not sleep). Treatment with cortisone ongoing from May 2021, at an unspecified dose and frequency; and Nyquil (dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol) ongoing from May 2021, at an unspecified dose and frequency; both for rash. At the time of the report, rash: not resolved; and insomnia (could not sleep) outcome: unknown.
shoulder was slightly sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR122462   Additional Information: GSK Receipt Date: 13-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingles vaccine. The patient did not effect at all. The patient experienced shoulder slightly sore for 1 day. Follow-up would not possible, as no contact, details were available. Additional Supportive Information: This case had been linked with US2022AMR122462, reported by same patient.; Sender's Comments:  US-GSK-US2022AMR122462:Second dose case/Same reporter