chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could not sleep; top of head was pounding, thumbing like her heart beat; Aching muscles; Stiffness of her neck (worse left side), upper back, across her shoulders and the top her left arm; Pain of her neck which was worse on the left side; Pain of her upper back, across her shoulders and the top her left arm; Right arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain of her neck which was worse on the left side), PAIN (Pain of her upper back, across her shoulders and the top her left arm), INSOMNIA (Could not sleep), MUSCULOSKELETAL STIFFNESS (Stiffness of her neck (worse left side), upper back, across her shoulders and the top her left arm) and PAIN IN EXTREMITY (Right arm was very sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, SIMVASTATIN, BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SELENIUM for an unknown indication.    On 09-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was very sore). On 13-Mar-2021, the patient experienced NECK PAIN (Pain of her neck which was worse on the left side), PAIN (Pain of her upper back, across her shoulders and the top her left arm), MUSCULOSKELETAL STIFFNESS (Stiffness of her neck (worse left side), upper back, across her shoulders and the top her left arm) and MYALGIA (Aching muscles). On 15-Mar-2021, the patient experienced INSOMNIA (Could not sleep) and HEADACHE (top of head was pounding, thumbing like her heart beat). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 17-Mar-2021, HEADACHE (top of head was pounding, thumbing like her heart beat) had resolved. At the time of the report, NECK PAIN (Pain of her neck which was worse on the left side), PAIN (Pain of her upper back, across her shoulders and the top her left arm), MUSCULOSKELETAL STIFFNESS (Stiffness of her neck (worse left side), upper back, across her shoulders and the top her left arm), PAIN IN EXTREMITY (Right arm was very sore) and MYALGIA (Aching muscles) outcome was unknown and INSOMNIA (Could not sleep) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient experienced redness that went halfway down her arm per mother via telephone. Pt was not seen in the office.
Patient developed cellulitis post ZOSTAVAX administration. PCP was seen and Cephalexin 500 was prescribed.
Wednesday, March 24th approximately 5:00 I became very fatigue and slept for a couple hours.  When I woke up I was very nausea and had a dull headache.  I ended up with dry heaves during the night. Thursday, March 25th I was still fatigue and try to some broth and kept it down.  I took some 2 advil - 250 mg. in the afternoon for the headache and slept most of the day.  During the night I had the dry heaves again and the headache persisted and still very tired.  Friday,  March 26th I called my doctor to see if I could get an appointment to see him and he did a telephone conference with me.  He said I was having a reaction from the Moderna vaccine and he prescribed Ondansetron 4 mg - 1 tablet every 4 hours as needed for nausea.
Soreness, heat, hard lump at injection site x7 days. Continues to be tender to palpation. Gradually improving but unusual length of time.
Patient received vaccine, within 5 minutes had respiratory distress and severe wheezing. Wheezing continued as of 10/20/21, responds to prednisone. Did complain of some chest pain,
Pt had swelling and redness at site of injection and then vomited later that night. Next day she was fine.
Pfizer-BioNTech Covid -19 Vaccine EUA  2/6/21 mild headache, body aches around 1800 hours. Insomnia, vivid dreams, body aches and feeling cold around 2300 hours.  2/7/21 fatigued, body aches  2/8/21 severe fatigued, stronger headaches, body aches, swollen lymph nodes - contacted primary care (waiting for nurse to return my call. I was able to get an appointment online for March)  2/9/21 mild headaches, a large purple bruise on left inner thigh. Lymph nodes are still painful. (I called my primary care and I?m waiting again for the call back)
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 57-year-old male patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and rash. The patient was treated with diphenhydramine and hydrocortisone. On 3rd August 2018, the outcome of the injection site rash and rash were recovered/resolved. It was unknown if the reporter considered the injection site rash and rash to be related to SHINGRIX. Additional detail were provided as follows: The pharmacist reported that patient experienced a rash which was spread from their injection site to their chest and back. The patient was treated with diphenhydramine and hydrocortisone. The reporter did not have expiration date.
Patient had no adverse effects or other symptoms as a result of administration.; vaccine was administered following multiple temperature excursions.; This spontaneous report has been received from a office manager referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided.Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 13-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5ml once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided)as prophylaxis following a temperature excursion for total time of 96 minutes. Excursions occurred between 11-MAY-2022 and 28-JUN-2022, no excursions prior to 11-MAY-2022, on 06-JUN-2022 a temperature of 5.9  Fahrenheit degrees (F) for 6 minutes, on 11-MAY-2022 a temperature of 5.7 F for 7 minutes, on 27-MAY-2022 a temperature of 5.7 F for 5 minutes, on 27-MAY-2022 a temperature of 5.9  F for 6 minutes, on 09-JUN-2022 a temperature of 5.4  F for 4 minutes, on 14-JUN-2022  a temperature of 5.7  F for 7 minutes, on 17-JUN-2022 a temperature of 29.1 F for 39 minutes, on 20-JUN-2022  a temperature of 7.2 F for 10 minutes, on 22-JUN-2022 a temperature of 8.4 F for 3 minutes, and on 28-JUN-2022 a temperature of 5.2 F for 15 minutes. Patient has no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007832:Case Number 02211246 US-009507513-2207USA007847:Case Number 02211343 US-009507513-2207USA007826:Case Number 02211351 US-009507513-2207USA007928:Case Number 02211355
Patient received vaccination @10:10 Am and was advised to wait in the waiting Area. Around 10:15 am patient  reported dizziness. Pt was given ann inhalant. RPH checked for Pulse which was normal (68) and Blood Pressure was checked which was low (128/48). The induvidual was given water to drink. The Paramedics came in around 10:20 and checked on her. The Individual stated she was feeling better and wanted to go home. A phone call was made after 3 hours to check on her. the Individual stated she was fine.
Patient received FluBlok vaccine at 11:49 am. She noticed tongue swelling approximately 25 minutes after receiving the vaccine. She waited at least 15 minutes in the pharmacy waiting area before leaving and noticed the tongue swelling as she was driving back to her office. EMS was called 54 minutes after she received the vaccine. EMS took her to a local ED where she was treated and released. The swelling in her tongue and tingling in her throat continued for several hours after arriving home on the evening of vaccination but subsided by this (next) morning. Her primary symptoms were tongue swelling, and "tingling" sensation in back of throat and right cheek, and elevated BP was noted upon assessment while waiting for EMS to arrive.
What I now have learned is Covid Arm: Barely any arm discomfort immediately after injection but 1 week after vax, arm was tender and itchy, a welt raised, injection site felt feverish, redness appeared at surrounding area. GP prescribed antibiotic.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding to medical history/concurrent conditions and concomitant medications. On 06-JUN-2014, patient was inadvertently administered with a dose of liquid PEDVAXHIB (dose, dose number, route and lot # not reported) that had been improperly stored. No adverse effects reports. Additional information has been requested.
Quite sick from the first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Quite sick from the first vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Quite sick from the first vaccine). At the time of the report, VACCINATION COMPLICATION (Quite sick from the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not provided.
A few seconds after vaccine was administered the vaccinator turned around to notice patient was unconscious. Vaccinator describes 20-30 seconds of full body shaking. Patient then awoke and was Alert and oriented to people, place and time within 2 minutes. He was nauseas and anxious initially. Onsite EMS was alerted immediately and came to access the patient. 911 was also called quickly under the assumption it may have been a seizure. Patient denied any seizure history. Father arrived a few hours later to pick up patients vehicle and dog. Father informed me that patient was doing better at this point and was being prepared for departure.
Sore arm around injection site within hour of receiving. Fatigue within three hours of injection. Fever within six hours of injection.- Treatment:  2 acetaminophen and 3 diphenhydramine and went to bed. Six hours later later took two more acetaminophen and went back to bed. Fever went away but, the sore arm persisted. The arm is just annoying not debilitating. The alarm was expected since I get the same reaction with seasonal flu shots.
This spontaneous report was received from a certified nursing assistant regarding a 18 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. ON 16-MAY-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (dose and route were not reported, lot # M003435, expiration date 19-JUL-2017), that was outside the recommendations per prescribing information. There was no adverse event reported. Additional information is not expected s the reporter did not wish to be contacted.
Extreme chills/shaking Extreme sweating: Facial sweating had a weird consistency that was more viscus than normal sweat. Extreme back pain Skin felt like it was boiling, like needles were pushing out of my skin Extreme arm pain at injection point that ran down the arm Pressure in eyes, and increased redness in one eye, almost like vessels had broken Muscle pain and cramps Runny nose Sore throat/massive increase in acid reflux Diarrhea
This spontaneous report was received from a Healthcare Worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 06-AUG-2015, the patient was vaccinated with ZOSTAVAX instead of PNEUMOVAX 23. Concomitant therapies included acyclovir. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Swelling under left arm, assume it is lymph nodes; Sore left side neck/Trapezius muscles; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included gout and hypertension. The patient was allergic to allopurinol (MANUFACTURER UNKNOWN). Concomitant medication included febroxitone (MANUFACTURER UNKNOWN) for gout and irebesartan (MANUFACTURER UNKNOWN) for blood pressure. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 13:30, the patient experienced swelling under left arm, he assumed it was lymph nodes and sore left side neck/Trapezius muscles. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling under left arm, assumed it was lymph nodes and sore left side neck/trapezius muscles was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Duplicate vaccine administered to adolescent patient during a well child child. Patient was supposed to receive seasonal influenza, HPV, and meningococcal vaccines but was administered hepatitis A, hepatitis B, and varicella as they were showing overdue in system. Medical assistant failed to reconcile with the patient's vaccine history in computer, which contributed to the error. Medical provider contacted family to explain the situation, and there are no further concerns from the family or the care team at this time.
Trouble breathing/wheezing 1 to 2 days after vaccine administration. Taken to ER. Prescribed Prednisone and albuterol.
Nausea. Vomiting. Light-headed. Rash on right forearm.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 24 hours after the vaccination (NYE), my last knee was achy, first I did not correlate it to the vaccine, but by the end of the day I could not walk. The next morning (01/01) my knee was better but my left hand was very stiff and painful and in the afternoon my left shoulder was very painful and I could not lift my arm. Next day (01/02) my shoulder was better but my left hand was swollen and very painful.  I went to bed with a swollen hand and next morning (01/03) the hand was a little better, maybe 80% better, but my right shoulder was ridiculously sore that I could not lift my arm and I could not go to work because of that. That day I also had stiffness on both hands. I went to bed that night and when I woke up my shoulders and knees were ok but my hands were still stiff and sore.  My feet were painful and bluish. Woke up the next day and my feet were fine but then my right hand was like 5 times its normal size, I could not open or close it, and that is when I ended up at the ER with lots of joint pain, my feet and knees were hurting again and I also had shortness of breath and   chest pains at that moment. They prescribed me prednisone for the swelling. The day after the ER my fingers were numb, I totally lost the feeling on my fingers until 01/28/2021.
Their super painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included itchy rash, shingles, blister and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-MAR-2023 Reporter Comment: This case was reported by the patient via interactive digital media. The patient got them in 2002, started as a itchy rash, she/he called her/him mother to ask her what to put on it she said get you some aveeno oatmeal bath powder, that'll work so she/he did. The warm water did soothe and made it feel better however afterword about 30mins later, that rash turned into blisters that were extremely painful wearing a shirt to the hospital and driving myself a nightmare its noooo joke. Those shingles injections are worth it. The only drawback their super painful afterwards for about 2 weeks. Follow-up would not possible as no contact details were available.
Patient reported feeling ill starting at around 11 PM, very tired. On 4/15 began severe flu like symptoms, nausea, vomiting and ended up blacking out and falling and injuring her face/arm. She has a regularly scheduled MD appointment on 4/16, still had flu like symptoms. By 4/17 she was starting to feel better. Her MD recommended that we record this as an adverse reaction.
Abscesses of skin; This spontaneous case was reported by a consumer and describes the occurrence of SUBCUTANEOUS ABSCESS (Abscesses of skin) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (After receiving 1st dose of vaccine, 6 Abscesses were appeared, One on lower back and other on right tight and). Concurrent medical conditions included HIV disease (Not Detectable). Concomitant products included COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA) for HIV disease.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-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 experienced SUBCUTANEOUS ABSCESS (Abscesses of skin). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at an unspecified dose and frequency and Surgery (third one on left arm, right under the wrist, after second dose of vaccine) for Subcutaneous abscess. At the time of the report, SUBCUTANEOUS ABSCESS (Abscesses of skin) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-203102 (Patient Link).
mom repts pt recvd vax & devel hives next am; friday eve penis swollen; urine bloody & t 103.7; hives inc; to er; tx w/ DPH,sxs resolved; PARENT informed was vax;
slight swelling; redness at site; fever; tiredness; chills; general feeling unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 04:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; IRBESARTAN; SIMVASTATIN; FAMOTIDINE A. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown"; PYREXIA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "fever"; MALAISE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "general feeling unwell"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "redness at site"; VACCINATION SITE SWELLING (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "slight swelling"; FATIGUE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, pyrexia, fatigue, chills, malaise.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the COVID-19 vaccine. About 10 hours after the second booster shot and for another 24 hours the patient experienced slight swelling and redness at site, fever, tiredness, chills, and general feeling unwell. Acetaminophen was taken as treatment for adverse events.The patient had not tested positive for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Upset stomach.headache.dizzy.abdominal pain.high pulse rate over 103 at rest. Chest feels racey.
Patient states she starts feeling pressure on her head on 01/26/21, 30 mins after her vaccine.  On 01/27/2021 at 8:00am, patient complained of dizziness, headache , nausea and vomiting.
No adverse effects.; received one dose of MMR II (R036582  12/17/2020) and one dose of VARIVAX  reconstituted with expired DILUENT; Information has been received from a office manager referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 15-JUL-2019, the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (therapy type: Albumin status rHA (recombinant Human albumin)) (lot # :R036582, expiration date:17-DEC-2020, dose, frequency and route were not reported) and one dose of varicella virus vaccine live (oka/merck)(VARIVAX) ( lot #: N021582, expiration date:09-AUG-2019, dose and frequency, route were not reported) reconstituted with expired  sterile diluent(lot #: N026990, expiration date:26-SEP-2018, dose, frequency and route were not reported) (expired product administered). Products had been stored properly with no temperature excursions. No adverse effects.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011428: US-009507513-1907USA011374: