chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/7 sore scratchy throat and congestion started to develop that evening. So I tested on an at home COVID-19 and it was negative. Symptoms continued but I continued to test negative. Symptoms felt like a bad cold  but worse. Began developing horrible sore throat and headache. 12/09 was advised to go to urgent care and urgent care referred me to ER for blood work for PAXLOVID. Began PAXLOVID the next morning. Symptoms continued 9th-11th. Symptoms began improving the 12th. Congestion persisted about a month but began to slowly resolve.
after about an hr i started to get shortness of breath and  heart tachycardia, i felt like i was running. it lasted about two hrs.  heart rate stayed in the 90s and its usually in the 60s for about an hour
Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 31 Oct 2022 Reporter comment: This case was self reported by the patient. The patient received both doses of Shingrix in 2019.  The patient recently experiencing Shingles. The reporter did not consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
cluster headaches; headaches got worse and worse and worse; not getting any sleep at night; tired; facial pain; Trigeminal neuralgia; phantom pains; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse) and INSOMNIA (not getting any sleep at night) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pains). On an unknown date, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain). At the time of the report, TRIGEMINAL NEURALGIA (Trigeminal neuralgia), PHANTOM LIMB SYNDROME (phantom pains), CLUSTER HEADACHE (cluster headaches), HEADACHE (headaches got worse and worse and worse), INSOMNIA (not getting any sleep at night), FATIGUE (tired) and FACIAL PAIN (facial pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, Diarrhea, Heart Burn. Heartburn. Diarrhea beginning Saturday, July 24 around 6:30 AM.
Headache, Myalgia, Fever,  muscle pain in lower back temp 100.7 h/a fatigue Narrative:
Severe pain in shoulder and arm that pneumonia vaccination was given in. Unable to move shoulder or arm. Think the vaccine was accidently put into the deltoid because it was give her high up almost to the shoulder.
Mild soreness in arm for a few days post injection. A couple of months later I began having severe pain in my right arm on a daily basis. I was unable to raise my arm over my shoulder.  Scheduled an appointment with my doctor who examined my arm for dexterity and determined the issue was likely an "itis" so ordered an xray to rul out rotator cuff injury. Xray showed arthritis in shoulder joint and upper arm. Dr prescribed Meloxicam
There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck; Whole body ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever) and CHILLS (Chills). 14-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitants were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-056408 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056408:Dose 1
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route were not reported) lot # M03478 and expiry date: 24-OCT-2019 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009404: US-009507513-1707USA009636:
Child stopped having regular bowel movements and was experiencing severe gas pains, stomach pains, sleeplessness, and prolonged periods of crying.  Child went over 14 days without having bowel movement.  Parent had to administer several interventions to try to prompt bowel movement- anal stimulation, suppositories, and stool softener- all utilized after long periods of being unable to pass a bowel movement on her own.  All interventions done under the guidance and suggestion of pediatrician.  Child did not pass her own stools without assistance until approximately 12 weeks after Rotavirus (Rotateq) was initially administered.  Mother was breastfeeding during this time and began taking high amounts of probiotics to also help with GI health.
JOINT ACHE,NECK RIGID,NERVOUSNESS,NUMBNESS LEG,LOWER BACK PAIN,KNEES AND HIPS PAIN,PAIN EYES,PAIN JOINT,PAIN IN FEET,REFLUX,SKING ITCHING AND DRY, HEADACHE FREQUENT,LOS OF BALANCE,LOST OF VISION, COUGH FREQUENT, CRAMPS LEG,ARM,HANDS,LOWER BACK AND HIPS LOWER;SWELLING FEET ANS ANKLES,THROAT SWELLING AND CLOSING,VERTIGO VOICE ALTERATION,PROBLEM TO SLEEP
At 5:30, noted local redness reaction at injection site. Treated with an ice pack. NP checked lungs they were clear. Redness of skin over right leg and over varicella injection site of left leg. Also redness of arms. Tylenol given, redness subsided and child was afebrile.
Patient observed for over an hour due to symptom development including complaints of pressure in head, diaphoretic, swelling and increase muscle tone/rigidity in her left arm, tongue feeling thick. Brought to ED for care after an hour of observation.  In the ED, left arm rigidity/spasm worsened.    Here is the physician note: Patient's headache is improved.  She has no neurological deficits or subjective complaints or objective exam consistent with a recurrent CVA.  She has no evidence of significant anaphylaxis related to the immunization.  May be a recurrence of her underlying medical problems that she has been seen by neurology for something similar.  Possible unmasking of this is related to the Covid vaccine is difficult to determine.  We will have her work individually with our pharmacy, infectious disease team to determine whether she is a candidate for a second vaccination.  She would like to return home right now her CT labs are otherwise unremarkable I think this is reasonable.  Return precautions for more significant etiologies were discussed at length.   Received lorazepam 0.5 mg IV x1, diphenhydramine 25 mg IV x1, and methylprednisolone 60 mg IV x1.
p/recv vax pt on same day devel a red, painful & swollen upper lt arm; pt seen by MD & treated w/medrol & ice packs;
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 045C21A, 043B21A and 037A21B) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetes and Hypothyroidism. Concomitant products included METFORMIN, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and LORATADINE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:00 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:00 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Total 5 vials were affected. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past.   No treatment medication was reported by reporter.  Patient was never diagnosed with COVID-19.
1st dose Moderna adm  3/4/2021  developed mild flu like sx lasting 2-3 days. 2nd dose Moderna adm 4/1/2021 developed moderate  flu symptom..   Left arm injection site swelled to size of a peach.  On 4/3/2021 noted heart racing and chest tightness.   Her pulse 90-120 by home pulse ox monitoring.   Taken to ER by her mom.  She had blood work, EKG and rec to f/u with her primary care physician for "adverse reaction to Moderna".    4/5/2021 had office appt.  The PA stated an adverse reaction to the shot.   Her pulse 133 in office.  BP 138/70.   She has received a referral to a cardiologjst.    Continues to feel like her heart races, approx. 6 times today, with sharp chest pain or tightness.
pt recvd vax & exp sluggishness & devel redness at inject site;
Fore arm blotchy; Fore arm red; This is a spontaneous case, initially received from other non-health professional on 17-Jan-2019, concerning a female patient of unspecified age.  The patient previously received flu vaccine when she was pregnant.  On an unspecified date (two years ago as reported), the patient was administered INN Flu Vaccine Seasonal [influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported] for active immunization against influenza.  On an unspecified date, a few hours after vaccination, the patient's arm became red and blotchy. No treatment was given, and the symptoms were subsided after 2 days.  The outcome of the events was recovered on an unspecified date.  The reporter assessed this case as non-serious.  The reporter did not provide the consent to follow-up. Hence this case was considered as lost to follow-up.; Reporter's Comments: A female patient of unspecified age developed redness and blotchy, a few hours after administration of INN Flu vaccine seasonal. The company assessed the causality of the events as related to the suspect vaccine, due to plausible temporal relationship between the event and suspect vaccine.
Neuropathy; Vomiting; Severe coughing; Sick; Sputum; since the pfizer covid vaccine shot, all her pains have completely disappeared; sleeping for 2 days afterwards; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 as dose 1 single for COVID-19 immunization. Medical history included diabetic, neuropathy in her left hand and shoulder (gabapentin), pain was constant felt like a stabbing pain, prevented her from sleeping at night, she could not lift her left hand, slipped disc, pain in her neck (prednisone and another medication). Concomitant medications were none. It was reported that patient received 1st dose of pfizer covid vaccine on 13apr and was due for her second shot on the 4May. After the vaccination in 2021, stated she became very sick with vomiting, severe coughing with a lot of sputum and was sleeping for 2 days afterwards. States she was really concerned about her symptoms she went to urgent care on april 25th. stated the symptoms she experienced were all the symptoms of covid. She had a covid test done which was negative in 2021. Adds that prior to the vaccination, she had a history of neuropathy in her left hand and shoulder; pain was constant felt like a stabbing pain and prevented her from sleeping at night and she couldnt lift her left hand. She took gabapentin for the neuropathy and had been on disability since last year. Prior to the vaccination, she also had pain in her neck from a slipped disc and was given prednisone and another medication. since the pfizer covid vaccine shot, all her pains have completely disappeared in 2021, she has stopped taking her gabapentin and can lift her left hand. States I have 'felt so different since the shot'. patient was also diabetic. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
suspected vaccination faailure/ had my / shots in January / have had five outbreaks since then / last outbreak being severe; have had five outbreaks since then / last outbreak being severe; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine).   In January 2021, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingles shots and had five outbreaks since then. The patient stated that the last outbreak was severe. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
58 patients received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (58 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.   This case was linked to MOD21-157253, MOD-2021-365271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received on 27-OCT-2021 and updated event details (event verbatim).
itchy rash on left lower extremity about 1 week after vaccine; then 2 weeks after vaccine hives/itchy rash on left upper arm
145PM arms on fire, hives erupted on arms, face, back & soles of feet; 2PM took 415PM DPH syrup called clinic rested & then vision became blurred & became lightheaded & shaky 245PM tongue thickened;
Brain fog; Arm with limited mobility; Sight of injection got hard; Entire back was covered with a rash; Sight of injection swollen; Body aches; Pain in injection site arm; Joint pain; Headache; Stomach upset; Diarrhea; Shortness of breath; Hot flashes; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000, AFib since 2017, Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin) and Allergy to chemicals. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MOEXIPRIL for Blood pressure high, ALLOPURINOL for Gout, OMEPRAZOLE for Stomach upset, METOPROLOL SUCCINATE.   On 23-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Fatigue). On 24-Mar-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), MYALGIA (Body aches), INJECTION SITE PAIN (Pain in injection site arm), ARTHRALGIA (Joint pain) and CHILLS (Chills). 24-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache). On 21-Apr-2021 at 1:00 AM, the patient experienced FEELING ABNORMAL (Brain fog). 21-Apr-2021 at 1:00 AM, the patient experienced MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen). On 29-Mar-2021, ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), INJECTION SITE PAIN (Pain in injection site arm), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen) had resolved and MYALGIA (Body aches), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.    This case was linked to MOD-2021-058061 (Patient Link).
Immediate swelling at injection site, spread to whole arm (Left). Could not bend arm, extremely tender to touch. Chills started on 12/15/18 and nausea much improved today, but pt reports feeling overall unwell. Still arm stiffness, some swelling. Did seek urgent care before today's office visit. VS WNL.