chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had pain and swelling in left arm, injection site was hot to touch, lymph nodes in left underarm were swollen. patient went to urgent care and was diagnosed with cellulitis and given and antibiotic. patient is better.
4-5 papular vesicular lesion -arm, trunk and groin, low grade temperature, malaise.
Within 12 hours of receiving vaccine, arm swelled up at injection site to size of grapefruit. Swollen, hot, red. Pt advised to ice area.
FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE, EXTREME FATIGUE; FOGGINESS AND FEVERISH. SYMPTOMS BECAME MILDER AOUND 8PM ON 1/20 - TEHN OVERHEATED BUT CLEARERE. GRADUALLY GETTING BACK TO NORMAL TODAY 1/21. VERY DEHYDRATED.  TOOK ADVIL. DRANK LOTS OF FLUIDS
I had a lot of my hair in my comb and in my brush falling out after the vaccination. I bought over the counter minoxidil that I'm putting on my scalp. And I also read that castor oil was good for balding. Another friend the same age and with the same manufacturer had the same problem. Appointment for dermatologist in the future.
After receiving vaccine unresponsive and lowered to the floor.  Pt regained consciousness immediately an stood up and assisted to chair.  Pt unaware of events.  Diaphoretic, pale and shaky.  Fluids offered and VS taken. 110/70  P 88. Alert, dizziness persist.  Taken to medical evaluation area for further observation.  Pt took 16 oz water and 32 oz vitamin water.  Feeling better, no further dizziness.  BP 124/82 HR 77, Sat 97% RA. Discharge ambulatory and recommend to follow-up with PMD for any persistent symptoms or increase symptoms.
Severe myalgia both shoulders; This is a spontaneous report from a contactable physician. A 72-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), hypertension (HTN), history of autoimmune hemolytic anemia in the past, sinusitis, osteoarthritis, acute onset polymyalgia and diagnosis of polymyalgia rheumatica (PMR) on 09Jan. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) started at least for 1.5 years for polymyalgia rheumatica (PMR). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had acute onset polymyalgia and was diagnosed with polymyalgia rheumatica (PMR) by the reporter who was a treating rheumatologist on 09Jan2021. On 14Jan2021, after the second dose, the patient saw ortho for severe myalgia of both shoulders, and underwent C-reactive protein (CRP) and the results was 62 (unspecified units). She responded greatly to steroids with normalization of CRP and the diagnosis was being treated for at least one year five months with prednisone. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe myalgia both shoulders was resolved with lasting effects on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
sat. at 10:30pm to sun. 5:30am- chills/fever- felt like run over by train Sun. fever all day with tylenol- highest 101.8- very fatigue Mon. am felt better, afternoon around 2pm feeling flushed temp 100.3, tired
Had the shot Monday 10am.  In the evening my left are was extremely sore, I did not think this was unusual as this is not my first flu or pneumonia vaccine.  Tuesday morning, mild fever achy body - managed with ibuprofen but was very ill.  Wednesday - fever increased to 103, ibuprofen and tylenol were not working.  Started taking Thereflu that evening, was able to control fever taking every 4 hours day and night.  Arm - extremely red and swollen at injection site and my arm was completely unusable.  Thursday managed with Theraflu again all day until bed time.  Swelling started to go down some, redness was reduced in size.  Friday, today - fever is gone, redness and swelling has gone down considerably.  Still tired, slow and achy but a notable difference from the previous days.
This spontaneous case, initially received on 13-Sep-2016, was reported by a health professional and concerns a 73-year-old male patient. Weight: not provided; Height: not provided. The patient's medical history is unknown. Administration of company suspect drug(s): The patient received AFLURIA from 13-SEP-2016 to 13-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: 13049221A. Suspect product tolerated in the past: Unknown. Product stored correctly: Yes. No additional suspect drugs. On 13-Sep-2016, AFLURIA vaccine with particles and cloudiness floating in vaccine was administered to a patient / received the vaccine with altered appearance - no specific AE (adverse event) is reported for the patient at this time (special circumstances: poor quality drug administered without adverse event). The outcome is reported as unknown. Reporter comments: The reporter considered the event as non-serious (quality defect).
Dull lingering headache lasted approximately 30 hours.  fatigue; slept for over 12 hours.  Severe body / joint pain that started in mid back and spread to rest of body.    Worst pain was focused in lower back, hips, knees and ankles.  Climbing stairs was difficult.   Facility nurse said my face was flushed but I had no fever.   Symptoms were 90% gone  shortly after headache subsided.  I did need to call off of work on 03/07/2021.
fever; extreme fatigue; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020. Concomitant products included NIACIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZINC, BOSWELLIA SERRATA, COLLAGEN, CURCUMA LONGA, HYALURONIC ACID, PIPER NIGRUM, RESVERATROL (INSTAFLEX ADVANCED) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste). At the time of the report, PYREXIA (fever), FATIGUE (extreme fatigue) and AGEUSIA (loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Positive) Has antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included Multiplex Omega Vitamin  No treatment information was provded   This case was linked to MOD-2021-087491 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Received Additional Information document  on 22-APR-2021. Added new events
Moderna Bivalent Booster 0.25mcg was given not 0.5mcg, Wrong dose given.
exp 3 min generalized clonic sz; pt was limp & postictally confused afterwards; On the way to ER 2nd grand mal sz occurred required valium by paramedics; pt given Phenob in ER-arrested the sz; pt observed in hosp
Pt recv vax on 3/19/99; on 3/20/99 pt exp rash all over body w/ itching, blister, swelling; tx=Benadryl, Prednisone, Zyrtec
ARTHRALGIA, DROWSINESS, DYSPNEA, ERYTHEMA, FEVER, HEADACHE, MALAISE, WEAKNESS.
Muscle soreness, red, hot, itchy, mild swelling at site of PREVNAR vaccination. Patient advised to ice and take diphenhydramine 25mg po at bedtime and up to event 6 hours during the day if able.
This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main though was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient received COVID vaccine in left deltoid at 1320pm 12/21/21 administered by RN BSN signee. Slight bruising and scant amount of blood noted to injection site.  After injection stated, "I feel light headed and think I'm going to faint." Stated "I just finished working out and have not had anything to eat or drink today." Patient moved to floor on her back. BP taken 120/80 HR 66 O2 sat 99 on room air. Provided with gator aide and breakfast bar. Rested for 15 minutes.
per my immunologists I took a benadryl before the injection at 4pm, I developed a red rash all over my left lower forearm around 7- 730pm  it eventually faded.(  I had the fever,  aches and chills for 2 days after the shot and injection site pain) for about 1 -2 weeks after the shot I had intermittent episodes of shortness of breath and tachycardia, this lasted for approx.  2 weeks after the injection,  These episodes were like the ones I experienced during my contraction of covid in 12-2020, Except these episodes were much shorter in duration.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No Adverse event; Administered the vaccine to the patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No Adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant product use was reported.   Patient received half dose.   On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.   No treatment information was provided.
Very painful thumb on injected arm. Patient has been taking Aleve PM with little to no success.
SEVERE SEIZURES; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no history of seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total (Dose number in series 1), 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 numbers. No concomitant medications were reported. On an unspecified date, the parent stated "My daughter had seizures after Covid vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe seizures was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211212465-covid-19 vaccine ad26.cov2.s-severe seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Diabetic; Rheumatoid arthritis attacking; the third vaccination; Pain in shoulder; immune system went into hyper activity , body was on fire; body was in pain; Hidradenitis suppurativa was bleeding; allergies came back; body was producing more sugar; The initial case was missing the following minimum criteria: [(no suspect product)]. Upon receipt of follow-up information on [24Nov2021], this case now contains all required information to be considered valid.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4102526-00 (AbbVie).  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1146181) at citrate free for hidradenitis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "the third vaccination"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetic"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis attacking"; ARTHRALGIA (non-serious), outcome "recovered", described as "Pain in shoulder"; PSYCHOMOTOR HYPERACTIVITY (non-serious), outcome "unknown", described as "immune system went into hyper activity , body was on fire"; PAIN (non-serious), outcome "unknown", described as "body was in pain"; HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis suppurativa was bleeding"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies came back"; BLOOD GLUCOSE INCREASED (non-serious), outcome "recovered", described as "body was producing more sugar". The patient underwent the following laboratory tests and procedures: blood glucose: more, notes: body was producing more sugar. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sciatic pain, Muscle aches in the legs, Foot cramping. Inability to walk.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose in July 2018). In January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, 1 day after receiving SHINGRIX, the patient experienced fever, chills, fatigue and pain in arm. On an unknown date, the outcome of the fever, chills, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to SHINGRIX. Additional details were reported as follows: Approximately 24 hours later receiving SHINGRIX, the patient experienced arm soreness, fever, chills, shivering and fatigue. The symptoms lasted for about 3 days and were resolved. The reporter did not consent to follow up. This case has been linked with case US2019019135, reported by the same reporter.
This spontaneous report as received from a consumer refers to her daughter of unknown age who on "a year ago" in July 2011 was vaccinated with a dose 1 of GARDASIL (dose, route and lot # not reported). The consumer's mother, stated that her daughter took her first dose of GARDASIL a year ago and now their health care physician (HCP) was advising for her to take the 3 doses. The mother feels this would be a total of 4 doses of GARDASIL and called for asking if is this safe? The reporter did not want to provide any further information. At the time of the report, the patient's outcome was unknown. No further information is available.
Narrative:  Patient reported tinnitus following administration of 2nd dose of pfizer covid vaccine. No additional monitoring or treatment needed.
pt recv vax 5MAR98 * 7MAR98 3AM had gen sz w/T105;taken to ER-poss febrile sz post immun;
PINS AND NEEDLES IN ARMS, HANDS, FEET, FACE, LIPS. FELT DRUNK AND DISORIENTED. COULDNT FOCUS EYES. NAUSEA. JOINT WEAKNESS. MUSCLES LOCKING UP.
This spnotaneous report as received from a physicia via company representative refers to a female patient of unkonwn age. On 30-MAR-2009 the patient was vaccinated with first dose of GARDASIL with lot # 0843X and unknown expiry date, (dose units and route was unspecified). On 08-JUL-2009, patient was administered with second dose of GARDASIL wiht lot # 0100Y and unknown expiry date. On 04-AUG-2010, third dose of GARDASIL with lot # 1099Y and unknown expiry date was administered. On an unknown date recently the patient was diagnosed with polycystic ovarian syndrome after she received the three doses of GARDASIL. The outcome of polycystic ovarian syndrome was unknown. No further information was provided. Additional information has been requested.
Patient began to have extreme itchiness in both arms and developed a rash on inner aspect of left elbow within 10 minutes of vaccine. Patient was given 50mg Benadryl IM. Her itchiness and rash resolved after 40 minutes.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 16-JUN-2015 the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) (lot # L000454, expiration date: 06-JUN-2017, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Initial unsolicited misuse report received from a consumer on 21 January 2016. This case involves a 06-year-old female patient who was vaccinated with a dose of ACTHIB (batch number, expiry date, route and site of administration were not reported) on 21 October 2015. The diluent's batch number was UA016AA and expiry date was 03 February 2001. The patient's illness at time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as PMH bronchitis. Concomitant medications were not reported. On 23 October 2015, two days following the vaccination, the patient had developed red bumpy rash at the injection site. It was reported that after evaluation by nurse that the rash was most likely due to the adhesive on the bandaid. It was an expired vaccine used. It was reported that the lot number provided was for ActHIB diluent that expired in 2001. Laboratory data and corrective treatment was not reported. The outcome of the event was reported as unknown. Follow up information received from consumer on 01 March 2016. The patient was vaccinated with 0.5 ml dose of Flu shot (batch number- UA0166AA, site of administration not reported) intramuscularly on 20 October 2015. The patient also received ActHIB vaccine with expired 0.4% saline diluent. The patient's previous vaccination history was provided. It was reported that the vaccination history records looked suspicious. The paperwork which was used to transcribe the informaton was shredded but the lot number (UA016AA) was not carried by clinic. On an unspecified date, following the vaccination, the patient had experienced red scab mark (with aid adhesive) and rash surrounding the area of left arm and redness and swelling at the vaccination site. The patient's face was blotchy and the patient cried, tired and had puffy eyes. It was reported that the rash was probably from the bandaid adhesive. The patient had received Benadryl as corrective treatment. The patient's mother ran warm soapy water over the area. The alcohol was used to remove remainder adhesive. The outcome of the event of rash was not recovered (it was reported that the rash did not go the "next day". The outcome of event scab, tired, blotchy and puffy eyes was not reported. List of documents held by sender: none.