chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.            Concomitant medications reported were Otezla (apremilast), Blood Pressure medications. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.
Patient reported tingling in tongue for ~30 minutes following vaccination.  Monitored for 40 minutes and left clinic without symptoms.
Both my wife and daughter have been to the ER for symptoms that I have also now developed.  I have very low energy and seizure like spasms.
had lack of appetite before second dose. When received the second dose, he started vomiting on the way home. Was sick on and off for the next few days. Died suddenly on 2/23/2021
1st dose 01Oct2020, 2nd 28Nov2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 1st October 2020).   On 28-NOV-2022, the patient received the 2nd dose of Shingrix. On 28-NOV-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 01Oct2020, 2nd 28Nov2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Swollen lips; Memory fog; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced swollen lips and memory fog. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lips and memory fog was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Received call from mother on 12/7/04 stating patient had a fever (100.2 oral pacifier thermometer) and child's fontanelle was bulging and he was irritable. At doctor's request, mom took patient to E.D. for evaluation.  At ED, the MRI report was normal.  Lumbar puncture was 21 WBC and TNTC RBC's with normal protein and sugar and the CBC showed a WBC of 28,000 with 70% PMN and one band. Because of his improved appearance and softening fontanelle, he was sent home after receiving Ceftriaxone. He had follow up appointments on 12/8/04 and 12/9/04. He received Ceftriaxone 12/8/04.  His bld, csf, urine cultures were negative on 12/7/04.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-FEB-2017, the patient was vaccinated with an expired dose of VARIVAX (lot # K026385, expiration date: 15-DEC-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Delayed type hypersensitivity reaction. Patient developed generalized weakness and rash one week after vaccine administration. Rashes red with raised borders. Rash most prominent on upper thigh bilaterally and in the lower abdomen.  Rash is very itchy and patient has been taking Benadryl 25 mg every 4 hours on Monday.  On Tuesday she took total of about 150 mg of Benadryl. Since Monday she complained of extreme weakness. Patient came to the emergency department because of the severe generalized weakness. Patient started on triamcinolone cream with no improvement and progressed to oral prednisone. Discharged with prednisone taper and triamcinolone cream.
HPV vaccine given 2/20/12 -> Pt. called 2/22/12 to report elevated fever & rash since Monday 2/20/12 evening. "No S.O.B.". Temperature 100 degrees with 102 degrees as highest. Reports taking ibuprofen/BENADRYL as directed & cannot afford to go do MD or the emergency room. Rash is "blotching" on arms, legs, thighs - "no itching, no swelling".
Starting August 10 I became sick with COVID like symptoms. I started experiencing sob, chest pains, and cough. I went to the doctor on August 13, had a negative COVID test and was given a steroid injection and nebulizer treatment and inhaler and antibiotics. I was diagnosed with asthmatic bronchitis. None of that improved anything.  On August 20 doctor called in more medication because I was still sick. On August 21-24 I started having low O2 levels. I ended up in the ER on 8/24, I was given a nebulizer treatment, and I was diagnosed with reactive airway disease and to follow up with a pulmonologist. I was sent home on 8/24 from the ER with steroids and cough medication. On 8/26 I was even worse so I went back to the ER, I was given a full respiratory panel and diagnosed with RSV. I was almost admitted because I could barely pass my walk test. I am still sick today.
pt recv vax 4FEB97 & 15MAR97 pt devel 22 1mm erythematous vesicles scattered individually on neck, back, arms & scalp;all of the vesicles erupted over the disappeared in less than 2wk;
itchy with whelps, raised bumps, took Benadryl 5 hours later  currently on a histamine blocker
Slight fever (Lasted one day), Aches, Chills, Sore throat (lasted several days) Severe Joint Pain head to toe, (has lasted for several weeks, still ongoing)
She had two vaccines and one booster, and she feels it protected her from having severe Covid.; She had two vaccines and one booster, and she feels it protected her from having severe Covid.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had two vaccines and one booster, and she feels it protected her from having severe Covid.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered pharmacist concerning a female who on 24-MAR-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # 658587/1520U) instead of ZOSTAVAX (Oka/Merck). It was noted this was not product confusion only human error. VARIVAX (Oka/Merck) was stored at a refrigerator range above the recommended range for at least 168 hours. The patient sought medical attention via the pharmacy. No symptoms or problems noted. A product quality complaint was not involved. Additional information has been requested.
Patient received COVID booster for ages 5-11 instead of the vaccine for 12+ that they should have received.
received fluarix after being exposed at -2.1°C; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number JN7YG, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: A health care professional reported that a patient received dose of Fluarix , a box of vaccines exposed at  minus 2.1 degree Celsius. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Fluarix exposed at  minus 2.1 degree Celsius, which led to incorrect storage of drug.
weakness; covid-19 positive; GI upset; diarrhea; loss of taste; loss of smell; decreased appetite; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weakness), COVID-19 (covid-19 positive), ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (diarrhea) and AGEUSIA (loss of taste) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2021, the patient experienced ASTHENIA (weakness), COVID-19 (covid-19 positive), ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (diarrhea), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (decreased appetite). At the time of the report, ASTHENIA (weakness) had not resolved, COVID-19 (covid-19 positive) had resolved and ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (diarrhea), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (decreased appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Oxygen saturation: 90 percent (Inconclusive) 90%. On 24-Jan-2021, SARS-CoV-2 antibody test: unknown (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ASTHENIA (weakness), COVID-19 (covid-19 positive), ABDOMINAL DISCOMFORT (GI upset), DIARRHOEA (diarrhea), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (decreased appetite) to be not related.    IV bolus fluid administration is the other treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: FU received on 09-JUL-2021 -It was reported that the patient took the Pfizer vaccine, not the Moderna and had the listed side effects.
Initial report received from a non-healthcare professional via other company (Merck) on 11 March 2014. Other company number: 1-554678524. An 80-years-old female patient had received a dose of Tetanus Toxoid (Manufacturer Unknown) (batch number, dose number, route and anatomical side of administratoin and not reported) vaccine on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date patient had experienced "rash-spreading". Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the patient was unknown. List of documents held by sender: none.
It was reported in a published article, title as stated above that an infant "by eight months of age" had received "all of her childhood vaccinations." It was reported that the pt was vaccinated with Haemophilus B conjugate vaccoine (+) hpe B vaccine. Other reported therapy included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and a conjugated pneumococcal vaccine. It was reported that the pt "under one year of age" developed a severe local delayed reaction which resulted in "extensive cutaneous scarring to almost all of her childhood vaccinations received by eight months of age." Specific immunoglubulin titers, patch testing, gram stain and culture of aspirated fluid were done. The results were reported to be that specific immunoglobulin titers were unusually elevated indicating a vigorous immune response to these vaccines. A gram stain revealed numerous white blood cells, but no organisms. A culture was negative. Patch testing was positive at 48 and 72 hours for aluminum, but negative for thimerosal and formaldehyde. The etiology of the lesions in this pt were reported as "very likely to be secondary to a DTH reaction to the aluminum adjuvant contained "in" the vaccinations received." Sterile abscess was reportedly to be "unlikely" given the multiplicity of lesions and the high vaccine-specific immunoglobulin titers, both of which were atypical features of sterile abscess. It was reported that given the potential for permanent disfigurement, physicians should be cognizant of the possibility of local DTH reactions to adjuvants in vaccinations that enhance immunogenicity, but can cause severe cutaneous side effects. In patients showing signs of DTH like reactions to vaccines, preparations devoid of these components should be sought and administered in place of those containing the offending agents. Additional info has been requested.
Post vax, the pt developed erythema, slight induration, slight tenderness, and swelling at the injection site of right leg.
Rash - pink macules scattered over neck, torso, arms and legs 24 mm. Started 9 days after receiving vaccine.
Information has been received from a two licensed practical nurses referring to a 15 year old female patient. The patient had no known allergy. On 13-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot# was reported as L004014 with expired date 04-MAR-2017, dose and route were unspecified) for HPV prevention. No concomitant medication was taken by the patient On the same day, the patient experienced a syncopal episode immediately following the administration of the vaccine and recovered 15-20 minutes after the injection in the care of the two reporters for medical attention. No lab tests was performed. The patient was fully recovered from the episode on an unknown date in August 2015. Lot number L004014 is an invalid lot number for GARDASIL 9. This is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site from her upper arm to her elbow. The redness resolved in three weeks after the injection. The patient reported that she already followed-up with her physician. Partial information was provided. The patient was getting frustrated with the questions from this report and did not want to answer any other questions. Towards the end of the call, the patient reported that she had siblings (unknown number) that also experienced redness. The patient had denied permission to contact their physician. This case has been linked with the case US2018GSK153537, reported for her siblings. Clarification raised to confirm which vaccine the siblings received.
After the second vaccine the patient had a large swollen area starting at the level of her left ear extending down the face to about the jaw
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 31-JAN-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Rash arm , 2 spot on leg Headache never have them Muscle twitch in knee and butt cheek  Chest pain Shortness of breath Gut pain
Incorrect Administration of the Pfizer Covid-19 vaccine during a drive thru mass vaccination clinic as the recipient was only 14 years of age at the time of administration and current guidance from Pfizer is approved for ages 16 plus.  The recipient did not experience any adverse events related to the vaccination.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Pt was in waiting area when he started to have a seizure. He went rigid and flipped his chair hitting his head on the cement floor. He was taken to the EMS area.
This spontaneous report refers to a female patient of unknown age. The patient had drug reaction/allergy with butalbital (manufacturer unknown). The patient had shingles for six years, approximately since 2007. On an unknown date the patient was vaccinated with ZOSTAVAX single dose, subcutaneous. Dose, lot and expiry date were unknown. The patient reported that she received the ZOSTAVAX vaccine as treatment for an existing case of shingles. The patient reported that she still remained in extreme pain even after vaccination. The outcome of extreme pain was reported as not resolved. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a currently 70 years old male patient with no pertinent medical history and no drug reactions or allergies. On an unspecified date, the patient received recent (sometime in the last 20 years) vaccinations (unspecified # of doses) with (Merck) VARIVAX (lot #, dose and site of administration were not provided). No concomitant medication was provided. These vaccinations were required because he was showing no titers for varicella and was working at different healthcare facilities. Medical assistant noted that the patient stated after receiving the booster vaccination with (Merck) VARIVAX that he did not show any titers for varicella on an unspecified date. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was not provided. This is one of the several reports of the same source. Additional information is not expected.
"COVID arm" - red, itchy, hot, circular rash at the injection site that did not appear until 10 days after the vaccination.
She came into the pharmacy a week after her flu shot and had a bruise on her arm where the shot was given.
Fever at 7 days post vaccine administration measles-like rash at 10 days past. Resolved within 3 days. No treatment.