chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; shaking; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the second of seventeen reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. Consumer reported that multiple friends had the "regular side effects" of soreness in the arm but another one of her friends, which was the patient, also had COVID prior to getting the vaccine and had a similar reaction to the reporter of fever, chills and shaking on an unspecified date. Outcome of the events was unknown. Reporter asked if having COVID prior to getting vaccinated could cause worsen symptoms  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/ drug/ events, different patient
Patient vomited about eight hours after the shots. She developed a huge infection in the right arm where she received the Pheumoccoccal vaccine.  She spiked a fever, headache, chills.  Two days after the shot she went to an urgent care center.  She returned to see doctor on 11/22/2019 and 11/23/2019.  She then went to the ER at Hospital.
No adverse effects reported; a package with a product quality issue where there were markings on the outside of the syringe; a patient received one dose of PNEUMOVAX 23 from a package with a product quality issue where there were markings on the outside of the syringe; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information on concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 16-OCT-2019 the patient received one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R017900 with expiration date 26-MAR-2020; dose and frequency were not reported) intramuscularly for prophylaxis from a package with a product quality issue where there were markings on the outside of the syringe(product quality issue and poor quality product administered). No adverse effects were reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA011988:
Case number PHEH2012US023410 is an initial spontaneous report received from a consumer on 27 Nov 2012. This case refers to a male patient of unspecified age. He was vaccinated with flu vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly on an unspecified date 2-3 weeks before the time of this report. On an unknown date after vaccination he experienced asthma like symptoms and severe breathing problem. It was also reported that it was not known if the patient received FLUVIRIN or another flu vaccine. The seriousness, outcome and causality of the events were not reported. No other information was available at the time of this report.
Approximately 2 weeks after my Moderna Covid-19 booster shot, I woke with rashes all over my body that were warm to the touch and incredibly itchy. Upon scratching to soothe the itchiness, I developed raised marks that became hot to the touch and would sting/ itch more than before. I believe the correct term for this is Dermatographia. As of 2/7/2022 it has not gone away and after doing research, this is something that has happened to others as well after the moderna booster shot.
9MAR94 myoclonic sz twitches extremities not larger jerking; took deep breath p/slept for 45 mins; 10MAR94 myoclonic sz 938AM to 955AM; no high fever-bouts of fussiness; slept for 2 hrs p/sz;
Expired vaccine (expiration date 2/8/2023) administered to the patient on 2/9/2023.
Body ache; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW), ABIRATERONE ACETATE, PREDNISONE, FINASTERIDE, TAMSULOSIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.            Patient did not take any medication for treatment.
Inconsolable crying X 2 hours. Fever 101.2F (Ax). Right thigh red and hot to touch.
Patient experienced a syncopal event about 5 minutes after influenza vaccination.  She fell backwards and hit her head. C/o headache at the back of her head.  Vomited about 10-15 minutes after the fall.
Information has been received from a nurse concerning a female in her early 20's who on an unspecified date was vaccinated with a second dose of Gardasil. Subsequently, after the second dose, the patient reported that she experienced tingling all over her body but not necessarily at the injection site (not itching exactly). There was no intervention needed, non-serious, and no follow-up was needed. Patient was not pregnant. The outcome of the tingling was not reported. Subsequently, the patient did finish the series. Additional information has been requested.
2/3/21 Urgent Care-Had acid burn on complete groin area. Dr. never seen anything like it. Sent TO ER-No diagnosis-Prescribed Nystatin ointment. That finally took burn away and rash came in groin area, all over back and neck, then moved to arms and legs. 2/23/21 Got into Dr. office. He said Moderna caused an implosion to my Immune System. Lasted 5 weeks. Still have cough it caused. He advised Not to get 2nd vaccine due to severity of the problem.
24APR91 immun given; 27APR91 pt broke out in chickenpox; 1MAY91 pt spiked t106, seen by MD in ER; given APAP & cool baths; glands became swollen & pt refused to eat x 2 days; Had rash for 2-3 days; Was not hospitalized;
High Fever (101.9), nausea, diarrhea for 3-4 days, tongue coated, pains.  Symptoms started 2 days after flu vaccine administered.
Child ran fever day of shots. Two days after shots she vomited blood. I took her to the ER and the said she blood in stool as well. We transferred her to another clinic.
Arm sore within 15 minutes of injection. Stayed mildly sore for 1-2 days.  Within 7 hours, severe muscle cramps, particularly in the lower extremities. Causing me to writhe in pain.  Tense right sided neck and jaw pain. Severe occipital headache (felt like hit with a baseball bat). Trembling. No fever. Symptoms improved around hour 12 post vaccine. For 7 days following the vaccine, intermittent severe headache (again occipital, baseball bat feeling), whole body weakness, sense that legs would give out when walking (I am physically active and fit so this was very far from my baseline), muscles would burn and fatigue after short period of usage, sensation that legs from the knees down were sitting in ice water (felt cold, slightly numb, very weak). Symptoms were present for 7 days and would wax and wane in intensity.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 13:00 (Lot number: EW) at the age of 43 years as dose 2, single and administered in arm left, administration date 28Mar2021 13:00 (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: VIIBRYD; IRON; VITAMIN D [COLECALCIFEROL]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "Vaccine #1 and #2 had upset stomach and diarreha".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Broke out in hives all over body, very itchy some painful.  went to urgent care given allergy medicine regimen
Came in to the hospital for a GI Bleed and had a polypectomy peformed, and upon admittance tested positive for COVID-19. The patient was released from the hospital after about 3 days and is currently at home recovering  Doctor seeing him at the hospital.
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROBIOTICS NOS and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: elevated (High) elevated temp..         No treatment information was provided.   This case was linked to MOD-2021-416924 (Patient Link).
Covid -19 EUA. Sore left arm after dose 1 x2.5 days.  Sore right arm after dose 2,  slight headache evening of dose 2 and again next morning.  Right arm, upper back and shoulders achy as if worked out too hard morning after the 2nd vaccination.
Pain in hand; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in hand) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROQUINONE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in hand) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (Pain in hand) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        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 treatment information was provided by the reporter.   Reporter did not allow further contact
This spontaneous report as received from a registered nurse (also the patient's mother and the company employee) refers to a 16 month old male patient. the patient's concurrent conditions included asthma, chronic idiopathic urticaria, allergy to sulfonamides and allergy to clindamycin. On 29-MAR-2008, the patient was vaccinated with the first dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). On 06-AUG-2008, the patient was vaccinated with the second dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported). The vaccines were administered within a shorter interval than it was recommended, but no adverse effects were reported. On 08-JUN-2016, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 (lot # M003659, expiry date, 20-SEP-2017; route and site of administration were not reported). Concomitant therapies include PROAIR HFA, SINGULAIR, QVAR, loratadine (manufacturer unknown), ZYRTEC and BENADRYL. On 08-JUN-2016, a few hours after vaccination, the patient experienced stomach pain. On 09-JUN-2016 in the morning, the patient started vomiting. The patient did not seek medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of the stomach pain and vomiting was reported as recovered on an unknown date in June 2016. The relatedness between stomach pain and vomiting and VAQTA and GARDASIL 9 was not reported. Additional information has been requested.
Whole arm turned red across from shot - hot, body aches, sensitive to light, couldn't go in sun, fever, broke out in rash, red some on chest, face, itching, diarrhea, exhaustion. By evening I was experiencing symptoms.
13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (first 2 doses of Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster). On 06-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Hrs following vax began having difficulty breathing, stiff lt arm, stiff neck, red, hot swollen inject site; temp 101.8;took DPH & APAP went to work the following day had to leave early due to general discomfort;in bed;too weak to eat.
After HPV vaccine given patient passed out and had shaking of upper extremities for <5 seconds. He then came to and was coherent and acting like his usual self aside from some shivering.
8 days after my vaccine, my arm became swollen, red, and very warm to the touch.   I took Benadryl Saturday night and Sunday night.  My arm was back to normal on Monday, January 18th.   I work up Thursday, January 21st, and my arm has a red circle and warm to the touch.
Patient experienced nausea and weakness within hours after receiving Td vaccine. Patient completely recovered within 48 hours. Patient received Td as booster shot and recalled experiencing pain in the arm after previous Td administration, over 10 years ago.
Information has been received from a licensed practical nurse concerning a 14 week old patient who on 19-Dec-2007 was vaccinated with the first dose of Rotateq by mistake.  No medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Patient says  a few hours after getting the vaccine he developed a rash. he is still getting episodes of rash. He says the rash started on the Monday and per our records his vaccine was given on a Friday
pt recvd vax; pt became lethargic, sleeping for 10-12 hrs & was difficult to awaken;
Pt returned to office on 1/7/08 for well care - waking this AM and shaking and off balance X several weeks. Low grade fever in office - "eyes shaking" wakes at night crying, irritable - 1/8/08 - child with shaking and unsteady gait "worse) - to ED. 1/9/08 Dad called did not go to ED yesterday - unable to start - seen in office - nystagmus - (L) arm tremor - ataxia, blood glucose 103 in office. Strong response of VZV reaction/side effect.
tenderness/tenderness and soreness is at the injection site; soreness/body aches; muscle aches; flu like symptoms; injection site soreness; Stiff neck; This is a spontaneous report from a contactable other HCP (patient). This 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), on 29Dec2020 at single dose in the right deltoid for More protection and prevention. Medical history included blood cholesterol abnormal. The patient had the virus before. He has positive antibodies. Concomitant medication included atorvastatin, 5mg or 10mg he can not recall, Once a day, Started this about 10-15 years ago and ongoing, To control cholesterol levels. He received Covid vaccine on 29Dec2020 and was experiencing some tenderness, soreness, muscle aches, and flu like symptoms. When he says flu like symptoms, he has no fever but it is more like how a person feels when they are first starting to get the flu with the body aches and sore muscles. The tenderness and soreness is at the injection site, it was given in the right deltoid. Injection site soreness: Feels like he got punched really hard. Is not bruising. Very sensitive and tender. He has been moving his arm and getting the muscle to function. This started a couple hours after getting the shot. It was given in the right arm since he is right handed with the rationale that using his arm would help with the soreness. Achy muscles and stiff neck: Got these later on 29Dec2020. On a scale from 0-10, it would be around a 3-5. It is getting slightly better. He had this same response when he got his first flu vaccine a few years ago. The flu-like symptoms, the body aches and sore muscles, started on afternoon on 229Dec2020. The shot was administered about 10:15- 10:30am on 29Dec2020. The events are getting better, definitely not getting worse for sure. He has experienced injection site soreness and flu like symptoms: achy muscles and stiff neck, with no fever.  Weight: Between 197-198. The outcome weas recovering.
Information has been received from a registered nurse concerning a 7 year old male with no known medical history or allergies who on 24-SEP-1999 was vaccinated with a SC dose of Varivax (lot # "1074J"). There was no concomitant medication. There was no illness at the time of vaccination. On 13-APR-2006 the patient developed varicella with a rash on his body and a cough. Unspecified medical attention was sought and he was diagnosed on 14-APR-2006. No laboratory diagnostic tests were performed. He was treated with Benadryl and Sarna lotion. The patient's outcome was recovered. There was no product quality complaint involved. Additional information has been requested.
Patient called clinic and stated that during flu event, she felt like vaccine was administered away from midline. She states she doesn't believe it was higher or lower than usual when she receives vaccines. She states that initially it was painful, but after a week or so her range of motion was impaired. She states she wasn't sure if due to physical activity or injection.  She states she saw primary physician who believed it might be due to administration. She states that it is much improved now.
I started showing signs of a head cold (runny nose, cough) on 7-31-2021.  On 08-02-2021 I woke up with Pink Eye.
As described by mother: Popping noise in ears, couldn't hear vision blurred and was very bright, had red, blotchy rash with hives, heart racing, blood pressure evelated, lips blue, shaky, low grade fever. Saw doctor.
10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant medication was not reported. Treatment medication was not reported.  This case was for the 7th patient out of 10 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Mild hives on abdomen within an hour after MMR, varicella and HIB. BENADRYL 6.25 ml/2.5 ml given PO and good result.
This spontaneous report as received from a nurse, refers to a 76 year old female patient. The patient had drug reactions/allergies for penicillin, vancomycin, ferrous sulfate and sulfa drugs. The reporter stated that an unspecified nurse in the medical office had administered ZOSTAVAX (0.65 ml, in the arm). On 21-OCT-2013 and the patient experienced an adverse event. The ZOSTAVAX was administered on the back of the arm above the elbow into a large amount of fatty tissue. On 23-OCT-2013 the patient returned to the medical office and complained of a large bump at the site of injection. The injection site was red and inflamed and the patient was experiencing pain. Patient was treated for the redness, inflammation and swelling with an unspecified medication on an unspecified date, as the unspecified physician was concerned that it was cellulitis. As of today, 09-JAN-2014, the patient still had pain and discomfort at the site of injection but was no longer experiencing redness, swelling or inflammation. The outcome of the events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Clusters of discreet 0.5 erythematous annular lesions B/L thighs adjacent to injection site - 2 days after vaccine.
pt. complain of numbness and tingling of his left hand from the site of the vaccination to his fingers.  They symptoms were  resolved and the patient went home.