chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at the injection site; 18 year old female patient inadvertently administered Pentacel instead of Menactra; 18 year old female patient inadvertently administered dose of Pentacel; Initial information received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse in the United States.  This case involves a 18 years old female patient who inadvertently administered dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (wrong product administered and product administered to patient of inappropriate age) and patient who experienced rash at the injection site (vaccination site rash), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 08-Feb-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ337AAA and expiry date: 05-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same).  On 10-Feb-2021, the patient developed a non-serious rash at the injection site (vaccination site rash) two days following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data not reported.   The patient was treated with MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA).  At the time of reporting, the patient had not recovered from the vaccination site rash (also reported that rash does not go away in a few days).  Reporter relationship: health care professional (HCP), Product used: used still using product: no  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 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.
Information has been received from a nurse referring to another female nurse of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 09-AUG-2018, the nurse administrated M-M-R II (rHA) (lot# N013866, expiration date 04-MAY-2019) which reconstituted by sterile diluent (MERCK) (route, strength, dose, frequency, batch/lot # and expiration date were not reported) to a patient. The vaccine sprayed out of the syringe, and may have gotten in the nurse's (unspecified) eye. The nurse used sterile eye wash immediately after potentially being exposed to M-M-R II in her eye. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1808USA004956: US-009507513-1808USA004703.
Patient was very short of breath was found to have pulmonary embolism that was effecting heart function. This occurred 18 days after the vaccination. He was admitted to the hospital for further care.
"COVID arm"; rash circling the injection site; sensitivity and itching in the injection site; sensitivity in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site). At the time of the report, VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Patient reported no treatment for events was provided.
Pt recv vax on 2/17/99; on 2/18/99 pt exp diffuse erythema, inc warmth of left thigh
At 2mo visit patient smiled, followed 180 degrees, head was not steady, did not bring hands together. At the 6 month visit raked a raisin, followed dropped yarn sitting with support not without no head lag passed a cube hand to hand, did not bear weight on legs, gross motor delay noted at 12 mo 12/15/96, rolled to get to things did not crawl said hi and bye, stood at 15 mo did not walk at 15 mo, by report used 3 words at 12 mo. Not seen for 18 mo visit, at 2 12/16/97 speech noted as a problem "spanish speaking nanny".  On 4/23/98 seen for rash lack of interactive facial contact, no interactive play, no role playing with dolls or toys, hearing referal passed, social withdrawal problem and expressive language disorder diagnosed refered to developmental pediatrician. Patient has an autistic disorder.  The exact onset of this disorder cannot be ascertained. Her mother requests that I submit this report.  The patient received the full course of vaccines. 4th DTP-HIB 2/13/97, 3rd OPV 5/17/96, MMR MSD 0890D, 11/15/1996, 3rd HBV 5/17/1996 SKB 1991A2, Varicella 11/15/1996 MSD 1076D.
side effects were minor; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects were minor) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced VACCINATION COMPLICATION (side effects were minor). At the time of the report, VACCINATION COMPLICATION (side effects were minor) outcome was unknown.            The patient stated we were in our eighties. The problems we have were prior to the first shot.  Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Information has been received from a RN concerning a patient who on approximately 07/26/2000 was exposed to an individual who had developed chickenpox through secondary transmission after having been exposed on 07/10/2000 to a child, who had developed typical chicken pox spots following vaccination with varicella virus vaccine live. Approximately in late July 2000, the patient became fatigued and he experienced stinging in the lumbar region of the back. After approximately 4 days, blisters appeared at the site. On 09/19/2000, the patient was seen in the reporting physician's office. A physical exam revealed a macupapular vesicular rash around L2/L3 distribution on the right side. No weeping lesions or secondary infection were noted. Herpes Zoster was diagnosed and the patient was seen in the physician's office for a follow up visit and the herpetic lesions were well healed. Additional information is not expected.
Shortly after the first vaccination, I began experiencing swelling and pain in my joints, continuing to increase over time.  I still have this adverse reaction, and am very uncomfortable because of it.  The swelling and pain is primarily in my fingers and feet.  I have never experienced this before in my life, and have been unable to eliminate this reaction.
Multiple unprovoked bilateral pulmonary emboli with dyspnea on exertion. Hospitalized for two days with IV Heparin for 24 hours. Discharged on Eliquis 10 mg b.i.d. for 7 days then 5 mg b.i.d.
No illness at time of visit. Pt came in for 3 injections. After first 2 injections were given, pt leaned forward and passed out. Mother and nurse caught patient when leaning forward (no fall). Pt laid back on exam table, was coherent within 2-3 seconds. Pt was very pale. Pt's feet elevated and given juice to drink. Pt laid on table for a while, sat up for a while and stood after with no incident, left in good condition. 3rd injection held off for now per provider. Patient in office 35 min post-injection for monitoring. Provider believed pt had a vaso-vagal response to getting vaccines.
Headaches; fever 101.4; nausea; swelling; erythema at site; tenderness; neck stiffness; SOB; chest pain.
Pink rash approximately 3 inches wide and 5 inches long on left deltoid appeared day following injection, area was warm to touch for 3 days, then rash remained until 1/29/2021.
Began with headache and coughing. Went to urgent care with son in-law on 12/17/2022. Coughing deepened and had to sleep sitting up. Was prescribed PAXLOVID and I am also taking MUCINEX and cough syrup. My son in-law and I both tested positive for COVID-19. OTC drugs have helped with symptoms minimally. Also experienced runny nose and coughing up a lot of phlegm.
Irregular, tachycardic heart rhythm lasting several hours on the second night after vaccination; this did not recur with the second dose of the same vaccine which was from Lot #EL9266.
Patient received a total of 4 doses of the Moderna vaccine. No adverse reactions  observed. No treatment required.
Vertigo issues started 3 days after my 1st Injection while in bed sleeping when I would rollover.  Frequency has increased with time.  I have had an emergency room visit due to the severe nature including unable to walk or sit up without issues.  I have encountered nausea as well including vomiting.    The frequency of the vertigo is increasing with time.  I have been diagnosed with benign vertigo with no explained reason after my ER visit.  I am seeing an ENT specialist next week for further evaluation.    All symptoms have been onsite after the 1st COVID vaccine injection.
This spontaneous report as received from a pharmacist via company representative who received information from consumer and refers to a patient (consumer's friend) of unknown age and gender. The patient's pertinent medical history was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included unspecified influenza virus vaccine. On an unknown date, the patient experienced paralysis after receiving ZOSTAVAX and an unspecified influenza virus vaccine. The outcome of the paralysis was unknown. The relatedness between the paralysis and the vaccination with ZOSTAVAX was unknown. Upon internal review the paralysis was considered to be medically significant. Additional information has been requested.
Within 24 hours I spiked a 101.2 fever and begin having digestive issues. Gas, bloating, and diarrhea. I was weak and had no energy for 5-6 days. Since my second dose I experience almost daily bouts of generalized weakness, dizziness, and shortness of breath.
Initial unsolicited social media report received from a consumer (patient) via other company on 20-Jun-2017. This case involves a female patient (age not reported), who was vaccinated with IPV (VERO) (IPOL) (batch number, expiry date, dose, dose in series and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unspecified date, following the vaccination patient developed multiple sclerosis. Laboratory investigation and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: multiple sclerosis. List of the documents held by sender: none.; Sender's Comments: Multiple sclerosis was reported following IPOL vaccine however diagnosis was not confirmed. Exact time to onset is unknown. More details regarding patient's medical history, concurrent condition, exact time to onset, history of viral infection before vaccination, history of autoimmune disease and investigation reports would be helpful for the complete assessment of the case. Based on the available information no conclusion can be drawn.
GBS in thumbs, extremely unlikely diagnosis; Arthritis in hand, more than likely diagnosis; 1st dose on 01Sep2019, 2nd not received; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (prior vaccination with Zostavax).   In SEP-2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: GBS in thumbs, extremely unlikely diagnosis) (serious criteria GSK medically significant), hand arthritis (Verbatim: Arthritis in hand, more than likely diagnosis) and incomplete course of vaccination (Verbatim: 1st dose on 01Sep2019, 2nd not received). The outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the hand arthritis was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the guillain barre syndrome and hand arthritis to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome and hand arthritis to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The reporter was the patient.  He received Shingrix 1st shot in September 2019 and sometime after 1st shot during that period of time his primary care doctor diagnosed him with guillain-barre syndrome (GBS) in both thumbs since then he had had x-rays performed on his hands and the results of the x-rays were that more than likely the correct diagnosis was arthritis and extremely unlikely that the diagnosis was guillain-barre syndrome. The patient concomitant medication included as unspecified injections into his fingers/hands/thumbs.  The patient provided limited information. The reporter was unable to ask for his date of birth, doctor of medicine contact information, lot number etc. because he wanted to end the call.  The reporter did obtain his mailing address did inform him that safety might send him a letter. Till the time of reporting, the patient did not receive Shingrix 2nd shot yet (and more than 6 months had passed since shot 1), which led to incomplete course of vaccination.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown), for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23. The reporter asked if the patient could react to PREVNAR 13. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Client c/o redness, swelling and itchy at the site of injection was instructed to apply ice. On 12-3-01, symptoms resolved.
06/07/2022 I had a significant increase in the spots. I had another dozen. They were in clusters; most were on my torso and upper thighs in addition to some on my leg. My physician had me use clobetasol propionate cream that I had been using before. I still use it for a month, go off it for a month, then use it again for a month. I don't know if it is having any effect other than lightning the color of the spots.
Presenting with multiple small, itching, non-draining, red lesions on right distal arm/fingers, and 3-4 on left distal arm, appearing at one hour before evaluation.
Sore arm at first; fever at 102.0 F; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, on 11Feb2021 at 02:00 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. The patient previously received, on 21Jan2021 at 02:00 PM, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, for COVID-19 immunisation. Known allergies to cephalosporin was reported. Concomitant medications included esomeprazole sodium (NEXIUM) and fexofenadine hydrochloride (ALLEGRA). On 11Feb2021, at 07:00 PM, the patient experienced sore arm at first. Then developed fever, chills, body aches and mild headache. Fever, chills and body ache lasted approximately 12 hours. Highest temperature during fever was 102.0 Fahrenheit. No treatment was received. COVID was not tested post vaccination. The patient recovered from the events.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 41 year old female patient with sulfa and codeine allergy and a history of childbirth on 24-DEC-2009 who on 26-DEC-2009 was vaccinated with MMR II.  On 06-JAN-2010 the patient developed a pruritic rash on her chest and abdomen.  No medical attention had been sought.  No laboratory diagnostic study was performed.  The patient had not recovered at the time of this report.  Follow up information has been received from a registered nurse reported that a patient with a history of twins childbirth and no relevant diagnostic tests and laboratory data who was vaccinated with MMR II.  The vaccine was not given at the location of the nurse.  Subsequently the patient had fine red rash on trunk complained of itching.  Additional information is not expected.
Patient fainted after receiving her flu shot. Her mother caught her as she fell forward out of the chair so she did not fall to the floor. Paramedics were called to the store. Pharmacist who administered the shot, monitored with EPI pen next to him, but no sign of allergic reactions was presented. Epi pen was not given. Paramedics arrived and concluded as a vasovagal reaction.  Patient did not receive any injuries as a result of the incident and the paramedics did not feel for further hospitalization
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
No adverse reaction. 2nd booster dose administered 2 weeks early. Patient did not have actual CDC vaccination card, presented Docket app, with three dates of Moderna vaccines, 1/6/2021, 2/2/2021, and 8/18/2021. With the information presented the patient received a booster dose of Moderna 0,25 mL. Later when documenting the dose it was noted that the patient had received a dose of Pfizer vaccine on 12/21/2021 and the three  full doses noted for a primary series of three and the Pfizer being her first booster. In a follow-up call to patient she stated "I forgot I received a booster in December".
This spontaneous report was received from a Nurse, referring to an unknown number of patients of unknown age and gender. No pertinent medical histories, concurrent conditions and concomitant therapies were reported. On 04-AUG-2016, the patients were vaccinated with improperly stored VAQTA. Dose, route, lot #, indication and anatomical location were not reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 3 ; Moderna, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly overweight (BMI of 26-27)" (unspecified if ongoing), notes: Slightly overweight (BMI of 26-27); "History of TIA (1 event in 1992)", start date: 1992 (unspecified if ongoing), notes: History of TIA (1 event in 1992); "high blood sugar due to gestational diabetes" (unspecified if ongoing), notes: high blood sugar due to gestational diabetes; "high blood sugar due to gestational diabetes" (unspecified if ongoing), notes: high blood sugar due to gestational diabetes; "Hepatitis A", start date: 1989 (unspecified if ongoing); "Thyroid nodules" (unspecified if ongoing); "squamous and basal cell skin cancers (resolved)" (not ongoing), notes: squamous and basal cell skin cancers (resolved); "squamous and basal cell skin cancers (resolved)" (not ongoing), notes: squamous and basal cell skin cancers (resolved). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 3 ; Moderna, Dose Number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: 26-27. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 31Jan2023.
Initial unsolicited report received from a healthcare professional on 05-JUL-2017. This case involves a 61-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5626AA, expiry date: 05-APR-2019, dose, route of administration were not reported) in left deltoid, on 19-JUN-2017. Any other vaccinations within four weeks of vaccinations was reported as none. Patient had Laceration on stomach at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications included DEXTROPROPOXYPHENE/PARACETAMOL (Darvocet). On 21-JUN-2017 (since the am), two days following the vaccination, the patient has been having numbness tingling in her left arm, pain at the injection site with a lump noted at the site. She is also having weakness in the arm and difficulty using it due to pain. It was reported that the patient required emergency room/doctor visit. No lab test was performed. The patient was advice to treat it along with rest. The patient had not recovered from the events. List of documents held by sender: none.