chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Arthralgia, NauseaVomiting, INJECTION SITE PAIN Narrative:
Patient is a 31 year old  female who is referred for evaluation of  Left arm pain and paresthesias with onset in January 2021 and redolution of symptoms and then after the Covid vaccine, symptoms recurred in the left arm and although there has been some improvement, she still has numbness in hand and arm and pain disturbing her sleep..    Evaluation of a 31 year old right-handed woman with a distant history of right wrist fracture and overuse syndrome with right arm pain since 2020 (attributed to injury), who now presents with left arm pain since January 2021 with no clear trigger. Pain was initially in her in her anterior forearm. She initially suspected an overuse injury from compensating for her right arm injury. Then she started waking overnight with left medial arm numbness and worsened pain that would persist during the day. (Numbness would always resolve with repositioning.) Pain radiates from digits 4 and 5 (and slightly digit 3) with radiation all the way up her left medial arm. On symptom onset the pain would radiate to the shoulder and neck, but neck pain has resolved. Pain had initially improved then worsened in April 2021, with no improvement since then. As noted, between episodes of pain, she has no significant sensory loss. There is no weakness, though she does have pain with strong hand grip. On focused examination, muscle bulk and tone are normal. Strength is full in all muscles tested including bilateral deltoid, biceps, triceps, wrist extensors/flexors, pronation, supination, EDC, FDI, ADM, APB, finger flexors, hip flexors, TA, gastroc. Sensation in intact to light touch and pinprick throughout. Reflexes are 2+ in bilateral biceps, triceps, BR, patellae, and Achilles.  IMPRESSION:  Patient is a 31 year old year old female, who was seen today for evaluation of left arm pain and paresthesias.  Examination shows no deficits. EMG studies were normal.    Findings are most suggestive of brachial neuritis with relapse triggered by covid vaccine in April 2021.    PLAN and RECOMMENDATIONS:   (1) long discussion of diagnosis, favorable prognosis and management (2) trial of  Gabapentin 300 mg take 4 hs (3) We will see her in follow-up in 2 months.
Past the 6 month time frame for the 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on unknown date, 6 months ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, the patients were past the 6-month time frame for 2nd dose of Shingrix. The reporter did not ask for additional details as decision to file adverse event was made after call was disconnected. The reporter did not consent to follow up. This case linked with US2021117114, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117114:same reporter
Shooting pain radiating from shoulder to fingertips of the arm with injection.  Patient tried oral otc aleve, motrin and topical analgesic and cold compresses.  None of these treatment helps.  His pain level has remain the same since the morning after the injection of the afluria trivalent vaccine.
Beginning the night of the 27th, I had a headache and a low-grade fever. I woke up in the middle of the night with a 102.7 fever, severe migraine, severe body aches, leg cramps, sore throat/swelling, and chills. I alternated taking ibuprofen and tylenol to try to control the pain, to no avail. I used bengay and cool washcloths for pain and to cool off. These did not help either. I made sure to keep drinking water and pedialyte. I took benadryl to try to sleep and help with my throat swelling up, it did not help.  All of this was non-stop until the morning of the 30th. That morning when I woke up my fever was going down and I no longer had the chills. I still had the severe headache, body pains, cramping, swollen/sore throat, and now diarrhea. Today is 2/1 and I am still experiencing severe body aches, severe headache, leg cramps, "nerve pain" type feeling in my arms, GI issues, and a sore/swollen throat.
low fever; chills; body ache; light head aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had received first dose of the vaccine Saturday afternoon and on Mar2021 was experiencing side effects such as low fever, chills, body ache, and light head aches and wanted to know if it was normal. There were no unaddressed medical questions referred or forwarded to Medical Information. Outcome of the event was unknown, at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
So July 16th I went to the clinic because I had allergy symptoms that were not responding to typical remedies for 4 days I was also experiencing a low grade fever. As I was pulling up  to the building I suddenly noticed I lost my sense of smell. Felt like it went off like a light switch. I went in and they tested me for COVID-19 they did rapid and the longer one and both came back positive. Later I realized later I also lost my sense if taste. From then until July 28th my symptoms were low grade fever, hot and cold chills, fatigue, and missing a lot of work (working from home), I needed to take a lot of naps. Loss of taste and smell gradually started coming back beginning July 26th. July 27th I started to feel and then that night, I woke up in the middle of the night with a severe headache. I took Tylenol and waited 4hrs and took ibuprofen and nothing helped. When I woke up I woke up with a migraine.  So, I called the clinic and made an appt. He prescribed some medication for me that helped. The medication was Fioricet 50-325-40mg (combo of 3 drugs) . I had migraines for for a week and then headaches for a week. I woke up with headaches for the entire month of August. On the 29th I had another telehealth appt with Doctor because they were still really intense. He said the only way to make sure nothing was going on was to go to the ER and get a brain scan. So after you spoke with him I went to the ER. At the ER they did a CT scan and gave me a headache/migraine cocktail. The cocktail only worked for that night. They said to follow up with my primary doctor.  I followed up with Dr. and let her know I was still having headaches even after the pain medication and the migraine cocktail so she prescribed me something else. She prescribed Mobic 15mg daily for 15 days. I took the medication as prescribed and now I am fine.
c/o chest tightness/nausea BP 126/92 HR 84 R16 Spo2 96-98 RA
Fever 103.8F, severe fatigue, inability to urinate, lower back pain. Symptoms lasted for 36 hours.
Immunized on 1/15/03 and 2/19/03. Client reported that she was not pregnant nor would she become pregnant in next 3 months, call received from certified nurse midwife on 6/25/03 that client was in labor and had received immunizations from the dept of health while pregnant.
This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX. On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), muscle pain (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the fatigue and muscle pain were recovered/resolved and the outcome of the injection site pain was unknown. The reporter considered the fatigue and muscle pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that her husband experienced severe fatigue and muscle pain that lasted for about 10 to 14 days. Less than a year after vaccination, the patient experienced soreness at injection site. The HCP reported this adverse event to her husband's primary care physician. The HCP did not want to provide her address. This case was linked with US2018080685, reported by the same reporter.
Cellulitis from vaccine #1 of the shingles vaccine. Treated with antibiotics in emergency room. Given prescription for antibiotics.
VACCINE GIVEN TO 16/17 YEAR OLD; This spontaneous report received from a patient concerned an adolescent of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given to 16/17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given to 16/17 year old was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
intractable pain was gone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Intractable pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "intractable pain was gone".  Additional information: The reporter stated that after patient received the COVID vaccine, then the booster, intractable pain was gone for the first time in years.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the 1st dose, 2 days later, I started having numbness in my left middle finger (on the left side). Then I started getting electric shocks and jolts in that finger. It happened a few times over the next couple of days. Then my left and right foot started getting numb with vibration, more pronounce in the left foot. Then my right-hand fingertips (thumb, pointer, index) starting to get numb. Then the inside of my nose, roof of mouth and tongue started to get numbness. This is when I started to get very alarmed. I went to see my doctor who referred me to a neurologist. I did go see the neurologist and did all types of blood work and nerve conduction study and sent me to physical therapy. I got an MRI of my back and brain. The neurologist says I have fast onset of neuropathy. I have a follow up in October 2021. I am just using Tylenol and muscle relaxer to control the pain.
Expired dose of MENACTRA was administered with no reported adverse event; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via Media information (under the reference 00854200).  This case involves a 3-years-old female patient received expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was administered (Expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Frequency : once, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.5ML, Strength: standard except for Fluzone HD, lot U6785AA, expiry date: 31-Oct-2021] via intramuscular route at an left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "The caller stated that a patient was given an expired MENACTRA vaccination. Many pediatric vaccines need month for age."  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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 case was considered medically important (OMIC). Information regarding Prevnar was received from a pediatrician regarding a patient who received two doses on unspecified dates and developed invasive Pneumococcal Disease. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on unspecified dates. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A pediatrician reported that a patient received 2 doses of Prevnar, administered at 2 and 4 months of age (dates unspecified) and after several doses, developed invasive Pneumococcal Disease during an unspecified period of time. The reporter indicated that the patient recovered. No additional information was available at the time of this report.
Lost 10 pounds; diagnosed with a blood clot in his 'stomach'; couldn't eat; stomach hurt  'bad'; This is a spontaneous report received from a contactable consumer or other Non-health care professional (patients wife). A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 15Mar2021 (age at vaccination 68yearsold) as single dose for covid-19 immunization. She doesn't know which arm he got the vaccine in. Medical history included blood cholesterol from an unknown date and unknown if ongoing History: He took a small dose of Rosuvastatin for his cholesterol (he has taken it for a couple of years, and dose of it was reported as may be 10mg). Prior Vaccinations patient received flu shot but that was always in the fall within four weeks prior to the first administration. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported (He has taken it for a couple of years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported) on unspecified date (was around the beginning of March or maybe late February) for covide-19 immunization. Patients states that in the last 1-2 weeks, her husband started complaining that his stomach hurt badly. This past week, he went to a doctor, had a CT scan on 09Jun2021 and was diagnosed with a blood clot in his 'stomach'. He was being treated at home with Eliquis. her husband's age is 68 yrs .It was reported that she believes it is because of the pfizer covid vaccine as he was previously healthy prior to the vaccine. Patient had pfizer vaccines as they knew they couldn't see their grandchild if they didn't get it. They were kind of forced to. They were perfectly healthy all through Covid and went and did everything they wanted to and never got Covid. They did take vitamins. Then after the shot he has this. Reporter stated that stomach hurt started around the beginning of June, maybe 01Jun2021. He thought it would get better and go away, but he had no clue what it was. It didn't get better. He had to go see his internist, and they did a CAT scan on 09Jun2021 and that's when they saw the blood clot. They put him on Eliquis and on Omeprazole for some reason, probably to soothe his stomach. He slept through the night which he hasn't been able to, but he was now. Reporter stated that patient couldnt started around when all of this started. He just felt pain in his stomach, and he could hardly describe it to her. He quit eating or cut down his eating because he felt full he said. That was probably 04Jun2021 that started. When asked if this has improved, worsened, or is persisting, she states he will eat a little bit about half of what he used to eat. lost 10 pounds on an unspecified date. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of diagnosed with a blood clot in his stomach, stomach hurt bad.  Follow-up attempts are needed. Information on Lot/Batch number has been requested.
Recently he tested positive for COVID-19; Recently he tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: BN5318), on 03Mar2021 as dose 2, single (Lot number: EN6202), on 18Aug2021 as dose 3(booster), single (Lot number: FC3180) and on 16Mar2022 as dose 4(booster), single (Lot number: FJ6369) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Recently he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: He has continued to test positive for the 20th consecutive day for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient reported as he received 4 doses of Pfizer-BioNTech COVID-19 Vaccine, the last dose was on 16Mar2022. Recently he tested positive for COVID-19 and took Paxlovid from 12May2022 to 16May2022. It has been 20 days since he originally tested positive for COVID-19 and he still has not tested negative said that this is a rebound effect.He took Simvastatin, one 40 mg daily.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6202, lot FC3180 and lot FC3180 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
This patient had flu like symptoms, splotches on legs, numbness in feet, weakness, and vasculitis.
Rash on the back as eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Rash on the back as eczema) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported  by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Rash on the back as eczema). At the time of the report, ECZEMA (Rash on the back as eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-103381 (Patient Link).
Administered on 15-Jun-2021, 4 days from first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided; Sender's Comments: This is a case of expired vaccine used for this 68-year-old subject of unknown gender with unknown medical history, who experienced no adverse events after the expired vaccine was administered. The medication error occurred during the administration of a dose of Spikevax. The rechallenge was not applicable, as this is a case of medication error. The benefit-risk relationship of Spikevax in not affected by this report.