chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked with 2018SA290496 (same reporter). This case involves a 29 months old male patient who received a fourth dose on 19-May-2017 and fifth dose on 24-Aug-2017 of DAPTACEL (Batch number, expiration date, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. The patient also received a third dose of ACT-HIB on 19-May-2017 and 4th dose on 24-Aug-2017 as concomitant therapy. It was an actual medication error due to inappropriate schedule of vaccine administered (given fourth dose of DAPTACEL on 19-May-2017 and fifth dose on 24-Aug-2017). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
allergic to pneumococcal vaccines, Avelox, Benadryl, codeine, Darvon, Demerol, erythromycin base, hydrocodone, Influenza vaccines, Lasix, Neosporin af, Novocain, prednisone, Robitussin (alcohol free); This is a spontaneous report from a Pfizer-sponsored program. A contactable prescribing physician reported that a 76-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown) at a single dose and influenza vaccine both administered via an unspecified route of administration for immunization; erythromycin, guaifenesin (ROBITUSSIN alcohol free), meperidine hcl (DEMEROL), moxifloxacin hydrochloride (AVELOX), diphenhydramine hydrochloride (BENADRYL), codeine, dextropropoxyphene hydrochloride (DARVON), hydrocodone, furosemide (LASIX), miconazole (NEOSPORIN AF), procaine (NOVOCAIN), and prednisone, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications. The patient's medical history and concomitant medications were not reported. It was reported that the patient was allergic to pneumococcal vaccines, moxifloxacin (AVELOX), diphenhydramine (BENADRYL), codeine, propoxyphene (DARVON), meperidine (DEMEROL), erythromycin base, guaifenesin (ROBITUSSIN alcohol free), hydrocodone, Influenza vaccines, furosemide (LASIX), miconazole (NEOSPORIN AF), and procaine (NOVOCAIN), and prednisone on unspecified dates. The patient also had allergies with penicillins, latex, potassium-containing compounds, shellfish-derived products, sulfa antibiotics, and wheat. The action taken in response to the event for erythromycin, guaifenesin, meperidine hcl, moxifloxacin hydrochloride, diphenhydramine hydrochloride, codeine, dextropropoxyphene hydrochloride, hydrocodone, furosemide, miconazole, procaine, and prednisone and the outcome of the event were unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and erythromycin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and erythromycin has submitted the same report to the regulatory authorities.
Immediately after placement site bled, subsequent bruising and muscle spasms lasting 30-60 seconds surrounding injection site that continued occasionally one week post vaccination.
Took pfizer booster in August, by December had leukoplakia and mouth pain, diagnosed with tongue cancer recurrence
Fever of 103 and rigors or shakes/chills from 8pm to 10 pm. Would have gone to ER but hurricane  spinoff tornadoes were passing through
My wife had her second shot 2 days ago and she got like a golf form in her armpit; This is a spontaneous report from a contactable consumer (patient's husband). A female patient (reporter's spouse) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The reporter stated that his wife had her second shot 2 days ago and she got like a golf form in her armpit on an unspecified date in 2021 and should they be worried about that. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Neck and stomach were burning like fever; sore; fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: body temperature 100F was reported..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include Tylenol.Concomitant medications were not reported.   This case was linked to MOD-2021-018772 (Patient Link).
Patient got a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 11-MAY-2023, the patient received the 3rd dose of Shingrix. On 11-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient got a 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter stated that a patient got a 3rd dose of Shingrix.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.  The patient administered 3rd dose of Shingrix which lead to Extra dose administered.
benign accrural papulovesicular eruption, onset about 3 weeks post-injection. Similar reaction within two weeks of his influenza immunization 31 OCT 2019.
severe, itchy, swollen hives and rash on right side of face; severe earache and swelling in right ear; sore right shoulder at shot location; general muscle aches, fatigue and congestion; restless limbs; some swelling around right eye and "watery" vision;
Pt had an allergic reaction (Swelling, large painful bump, hot to the touch, throat swelling, increased heart rate). Pt went to the Emergency Room via ambulance where she was treated with EpiPen, Benadryl and Pepcid and stayed a while for observation. Pt was sent home from ER. She came to the pharmacy the following day to get those same meds filled that she had in the ER and her condition was fine.
UTI; an increased in frequency of her urine; got her booster shot last 27Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose, Location: Right arm, NDC, Lot, Expiration: Unknown), administration date: 09Mar2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Second dose, Location: Left arm, NDC, Lot, Expiration: Unknown), administration date: 30Mar2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Oct2021, outcome "unknown", described as "got her booster shot last 27Oct2021"; URINARY TRACT INFECTION (non-serious) with onset 28Oct2021, outcome "not recovered", described as "UTI"; POLLAKIURIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "an increased in frequency of her urine". The events "got her booster shot last 27oct2021", "uti" and "an increased in frequency of her urine" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of immunisation, urinary tract infection, pollakiuria. Additional information: Patient got her booster shot last 27Oct2021 and the next day, 28Oct2021, she noticed an increased in frequency of her urine, like a UTI. She stated she already had it checked and got two rounds of antibiotic. She also said that she was still experiencing this. She also stated she found others online who received the Pfizer covid19 vaccine who also experienced the same side effect as hers. Her question was, if this has been a reported side effect of the vaccine and if yes, how long did it last. No investigation assessment. She has been having a side effect of frequent urination. Caller states she has come to the conclusion that was from the booster shot. Caller states that it feels like a UTI, but there was no medicine and no cure. Caller states she had her booster dose on 27Oct2021 and she had no issue, then she woke up on 28Oct2021 the following day with frequent urinating and she has taken 2 different antibiotics that did nothing so it was not an infection, the only thing that was different was the booster. Caller states it was Bactrim 800mg and Nitrofurantoin, the generic Macrobid. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. Any AE(s) require a visit to: Emergency Room: yes, Physician Office: yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Diarrhea; Cramping; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic (Allergy to Keflex.) and Allergy to antibiotic (Allergy to Micins.). Concomitant products included THYROID (ARMOUR THYROID) for Thyroiditis NOS, NAPROXEN SODIUM (ALEVE), PROBIOTICS NOS, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping). The patient was treated with SIMETICONE (GAS X) at an unspecified dose and frequency. On 10-Jun-2021, DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021 contains significant information. Updated patient demographics, updated medical history, updated first dose information, updated stop date of the events and changed event outcome from unknown to recovered/resolved
arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelled up) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (arm swelled up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs include: birth control pills.
Fever of 103.5 F; severe headache; extreme fatigue; rash at injection site; muscle weakness overall
ongoing arm pain post administration; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 0180811(CLUSTER), 01808146 (CLUSTER) and 01808177(CLUSTER).  This case involves a 28 years old female patient who experienced ongoing arm pain post administration after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number:UT8076NA) (Expiry date: 30-Jun-2024) (with an unknown strength) via intramuscular route in the left deltoid for immunization.  On an unknown date, the patient developed event of ongoing arm pain post administration (pain in extremity) (unknown latency).  It was reported, Caller reporting 4 of their employees have experienced reactions after receiving FLUZONE QIV PFS, administered at their clinic as part of employee health. Caller reporting 3 patients have complained of ongoing arm discomfort and one patient experienced redness around the injection site. Caller reporting, she is concerned about continuing to use this batch of vaccines, she reports they have given over 70 FLUZONE QIV PFS and 4 have experienced reactions. Caller did not have any information as far as time frame of onset of symptoms. Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 3 Days After Vaccination in Adults 18 Years of Age and Older, including Grade 2 and Grade 3 injection site pain. 3: Injection site adverse reactions: redness/erythema. Caller also with question on whether we have any information we can send as administration guide as a reference for administration.Caller reporting patient is experiencing ongoing arm pain post administration. Caller does not have details on onset of symptoms, caller has not assessed whether patient is having any difficulty lifting her arm  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved for the event; Sender's Comments:  US-SA-2023SA322206: US-SA-2023SA322148:01808146 01808146:
This spontaneous report was received from a doctor of pharmacy refers to an approximately 86-year-old female patient with no drug reaction/allergies. Current conditions included diabetes, breast cancer and high cholesterol. The patient's history included heart failure. On 05-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H01258, expiration date 09-OCT-2013 and route not reported) Concomitant medications included atorvastatin, spironolactone, carvedilol phosphate (COREG CR), warfin, furosemide, anastrozole, alendronate sodium (manufacturer unknown), glyburide, APIDRA, levothyroxine sodium and losartan potassium (manufacturer unknown). Approximately on an unknown date in December 2012, patient developed a large red flat area at the injection site after vaccination with ZOSTAVAX. The area also itched and the itching kept her up at night. The area was slightly bigger than half dollar coin. an unspecified cream was given as a treatment for the events. The patient sought medical attention by contacting the pharmacist. At the time of the report the events did not resolve. Additional information has been requested.
I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again; itchiness; I skipped a cycle in August; Clotty kind of blood, which is abnormal than my regular period; I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose; I had chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) and PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, 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 experienced MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), PRURITUS (itchiness), MENSTRUATION DELAYED (I skipped a cycle in August), INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (I have been having two weeks of persistent abnormal bleeding, This abnormal bleeding began September 14, stopped after 3 days then began again), MENSTRUATION DELAYED (I skipped a cycle in August) and INTERMENSTRUAL BLEEDING (Clotty kind of blood, which is abnormal than my regular period) had not resolved and PRURITUS (itchiness), PYREXIA (I had fever after both shots, 102 degrees fahrenheit at first dose, and 101fahrenheit after second dose), CHILLS (I had chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant product was reported. Treatment information was not provided.   This case was linked to MOD-2021-351211 (Patient Link).
2/9/21Chest thumping,  3/2021 Fatigue, Shortness of Breath
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's historical drugs reactions/allergies included vancomycin and morphine. The patient's medical history and concomitant therapies were not reported. On 10-OCT-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M039452, expiration date 19-DEC-2017, subcutaneous in the right arm, for prevention of shingles (dose was not provided) reconstituted with sterile diluent (MERCK) subcutaneous in her right arm lot # M016886, expiration date 07-DEC-2018 (strength was not reported). Other suspect therapies, included influenza virus vaccine (unspecified) (manufacturer unknown) (strength, dose, route, frequency, lot #, expiration date and indication were not reported). In October 2017 (also reported as on an unspecified date after received ZOSTAVAX, the patient sought medical attention with her pharmacist, who reported that the patient experienced a raised red wheel about 1 1/2 to 2 inches at the site injection on her right arm, that did not hurt or itch. Laboratory diagnostics were not performed and no treatment was given for the events. The outcome of injection site mass and injection site redness was reported as not recovered. The assessment causality between injection site mass and injection site redness with ZOSTAVAX, sterile diluent (MERCK), and influenza virus vaccine (unspecified) (manufacturer unknown) was not provided.
I had my vaccination on 10/09/2022. Approximately in 01/2023 I started to experience tingling in legs and arms throughout the day. It may be a nerve thing but not circulatory. If I change position it will go away but can be scary when I am driving. I wake up every morning with one or both of my extremities being numb and sometimes swollen. I had tests done on 04/03/2023 to include a blood panel. All blood work was fine except the C Reactive protein was high. I am now being referred to a specialist. I am seeing specialist to be determined up to 3 weeks. I stopped taking the spironolactone to see if reaction to the medication last week but I am still experiencing the tingling.
The first 2 to 3 days after the vaccine felt like a normal vaccine. Pain and limited mobility from shoulder to elbow sometimes can feel pain in forearm has occurred since the vaccine. Pain is mainly from bicep down to elbow. Has been taking naproxen 500mg twice daily. has been feeling better since taking the naproxen but will be starting physical therapy on Friday 11.18.2016. Patient is not currently on any other medications.
Chest Pains, heart arrhythmia, trouble breathing. Had an EKG performed. No issues detected.  Issues have not gone away and come back periodically.  Plan to see Cardiologist for further testing.
Rash head to toe, fever, rash on legs looks like small red mosquito bites; rash on upper body looks like hives. No vesicles noted.
Father stated child was outside at school playing in PE. Started to have mild chest pain. Continue from 'noon until supper'. Did not seek medical attention. States the family moved here from another state and they are not used to the humidity. No further problems.