chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case has been downgraded to non-serious due to follow-up information received pertaining to event details. Additional concomitant vaccines and patient demographics were also reported. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced localized erythema and tender induration at the injection site. At 2 months of age, the patient received the first dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant therapy included ACT-HIB and PEDIARIX. On an unknown date, the patient received her first set of vaccines. Approximately 1 hour after receiving the PREVNAR vaccine, the patient developed a localized erythema and induration, which was tender. She had no cardiopulmonary compromise and no other systemic symptoms; there was no anaphylaxis. The patient improved after receiving TYLENOL and ice application. See related case(s): US-WYE-H01951808 (adverse event, non-expedited).
Pain started right after. Never got better.  Developed Frozen shoulder capsulitis.  Did physical therapy, cortisone injection and now having surgery on 1/12/23.  Been sore for over a year with limited mobility.
Patient had syncope (BP 85/52 -- > 106/68, RR 14 -- > 14), flushing/sweating, not alert for 9 minutes. BP dropped after passing out, put patient in Trendenburg position, gave orange juice. Patient alert & ate crackers. Advised to give second dose lying down. Patient stable, released from vaccination site.
Pop up Clinic. Patient received Janssen vaccine at 11:59. Immediately began experiencing allergic reaction. Assessed by RN. BP was taken 184/120, pulse 115, states 97%.  Patient  displayed the following signs and symptoms: Apprehension, Flushing and skin edema, numbness and tingling in extremities, itching, localized urticaria, , wheezing and labored breathing. Emergency was called and patient was given epi-pen in L thigh IM by Employee.
felt like she had a touch of the flu; Felt achy; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, LISINOPRIL for Blood pressure, SIMVASTATIN for Cholesterol, PAROXETINE HYDROCHLORIDE (PAXIL CR) for Depression, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) for Heart disorder, PROGESTERONE and ESTRADIOL (MINIVELLE) for Hot flashes, OMEPRAZOLE for Indigestion and Acid reflux (oesophageal), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, SOLIFENACIN SUCCINATE (VESICARE) for Urine abnormal, CELECOXIB (CELEBREX) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had a touch of the flu), PAIN (Felt achy) and HEADACHE (had a headache) outcome was unknown.            The patient was treated with some cough medicine. Patient was also having stool softeners for constipation as concomitant medication.
Interchange of vaccination products; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products). On 07-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) had resolved. Unknown          concomitant medicines was not reported by reporter   treatment information was not provided   The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessments.  patient had taken first dose of Pfizer on 10mar2021,on the same locations for both the doses    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUNE-2021.contai ns no new information
Patient reported fever 101.5 for a couple days, rash all over his chest, general malaise- lethargic, pain in the injection side and nausea.
Developed chills, achiness to R arm where had injection. Developed small rash, looks like shingles, under R arm. States they are painful.
Extreme fatigue, sleeplessness, weight loss, confusion and other severe cognitive symptoms that have increased over a period of 5 weeks.
Approx. 3 hrs after vaccine administration, Mom describes patient as non-stop screeching. This lasted from approx. 1 pm to 7 pm.
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
05/16/2005 Received Pediarix left anterior thigh, child resisted injection.  05/25/2005 Mother brought child to doctor - small knot on left anterior thigh, red, recommended to Mother, check with Pediatrician and phone called immunizations nurse with results.  05/26/2005 ER visit - bacterial infection - treated with anti-bacterial cream, continue warm compress.
Sore arm, rash at vaccination site then appearing around upper chest to base of neck and on upper tight arm over the next day to day and a half
Mother states that patient had large red bump on left arm where had vaccine on 11/18/2015. Mother states took patient to ER and they diagnosed with cellulitis and gave antibiotic. Patient states left arm was red/itchy/burning for 1 1/2 weeks after vaccination on 11/18/15. Vaccine given in this arm was documented to be Meningitis vaccine (MCV4, Menactra) given in left deltoid.
Momentary confusion; Memory loss; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Feb2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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 were not reported. On 23Feb2021 at 12:15, next day of vaccination, the patient experienced momentary confusion and memory loss. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events momentary confusion and memory loss was resolved on an unknown date in Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt noted neck stiffness, and tingling around neck/throat area. Pt requested 30 minute observation. When time was up she reported the symptoms. Pulse ox checked by MA, 98%, verbalizing coherently. Given Benadryl 25mg po and discharged to neighbor for transportation home. Pt given ER precautions and she verbalized understanding.
11-6-99 ---11/7/99, pt developed urticaria, induration and erythema.
After the vaccine on 5/18/21 he experienced extreme fatigue, thrombocytopenia, leukopenia, and anemia. After vaccine on 6/28/21 she experienced the same as the first vaccine + low grade fever for 5 days. After the third vaccine on 12/27/21 she experienced bradycardia (HR in the 40s). She went to the ER for chest pain on 1/2/22. Chest pain is now resolved, HR remains in the 50s, and she now is experiencing swelling in her ankles each morning.
Engerix-B 31may2022,  Twinrix jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   In July 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 8-Sept-2022 Reporter's comment: The lot/ expiration dates were not available. The reporter consented to follow-up. Additional supportive information: The registered pharmacist received one dose of Engerix-B and one dose of Twinrix (late 2nd dose for Hepatitis B) which led to wrong vaccine administered.
LEFT ARM MAGNETIC; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced left arm magnetic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left arm magnetic was not reported. This report was non-serious.
Day 1 7-8 hours later patient complained of leg aches, chills. Day 2 Low grade fever, leg ache, fatigue headache. Day 3 Temp 101, dizziness, headache. Day 4 Sore throat, saw pediatrician, strept negative, DX: Viral. Day 5 Complained of itching during sleep, woke up with giant hives all over body except for face and neck. Seen in ER, Adrenakin given. MD at first thought it was related to HBV, then after learning LMD thought it as viral, backed off on allergic reaction DX. Hives lasted until Day 9.
Received varicalla vaccine 4-7 2015 in (R) arm. Fever that night. Leg pain 4-15; Still present 4-18-> red maculopapular erythema (L) chest. (R) ileam, (L) flank, (R) hip. No systemic sx.
I received the shot on 5/12. On the evening of 5/13 starting around 5pm I had fever of 101.4 and chills which lasted through the night.  My fever broke the morning of 5/14.  My arm has a hard knot where I received the shot that is very painful.  This was reaction was within a few hours of receiving the vaccine. I still can't sleep on my left side as of 5/18, but the knot is getting smaller.  My lymph nodes under my left arm where I received the shot are noticeably swollen.  This happened most noticeably on 5/14 and remains swollen.
Redness, warmth and swelling to left deltoid, Malaise, shakiness, increased blood pressure
Injection site became very red and inflamed and continued to spread to entire thigh.  Seen in ED 8-10-13 and diagnosed with cellulitis and started on Keflex 250 mg bid.
This is a spontaneous report from a contactable consumer (medical assistant) via a Pfizer-sales representative. A 18-year-old male patient received TRUMENBA (lot number: 560256 and expiration date: 01Aug 2019), at a single dose; MENACTRA (lot number: U58338A and expiration date: 25Feb 2019) at an unknown dose; and hepatitis a vaccine at an unknown dose; all via an unspecified route of administration, on 27Aug2018 for immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced shortness of breath on 28Aug2018. The patient recovered from the event at an unknown date.
Red spots (rash) on back of hands, swelling of wrists, veins in wrists swollen, no itching
Mild headache for approximately 6 hours, followed by nausea for 4-5 hours, followed by stomach pain for a period of less than 1 hour. All symptoms gone 12 hours after beginning.
cold sore on top lip of mouth; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 at 14:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient had no known allergies. Patient did not take any concomitant medications. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, at 09:00 the patient experienced cold sore on top lip of mouth. Patient has not had a cold sore in over 15 or more years. That was continuing to worsen hence patient was applying NEXCARE. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included applying NEXCARE. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore on top lip of mouth was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.
pt recvd vax & fell towards floor; both arms & legs were twitching; was unresponsive; bp 140/76, p 72; to hosp;
Fever, chills, headache, cough, and body aches for 36 hours. 48 hours a cold  sore appeared on my upper lip
2 days post vax, the pt could not walk, developed L3-4 discitis.
This spontaneous report as received from a lawyer regarding a case in litigation refers to a currently 65 year old patient. On approximately 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced sepsis and was treated by a healthcare professional. At the time of the report, the patient's outcome was unknown. The reporter considered sepsis to be related to ZOSTAVAX. Upon internal review sepsis was considered to be medically significant. Additional information has been requested.
Day 8 after injection, a 3" diameter circle around the injection site became red, hot, swollen and itchy. The next morning I had 2 large hives ( red, hot, swollen, itchy patches) on my buttocks. They went away, but other hives appeared on my torso, arms, legs, soles of feet, rotating from place to place, until the morning of Jan. 24, day 12 post injection. During all those days the injection site was inflamed and swollen in 3" circle. I had a phone doctor visit on Jan. 21, was advised to take Benedryl. I emailed further questions to my doctor.  I have a appointment with an allergist on Feb. 4, prior to receiving the second dose, Feb 10.
Trouble breathing, continuous coughing, facial swelling, itchy, chills, weakness, nausea. Took triple doses of Albuterol inhaler and BENADRYL (1 dose). Took over 8-12 hours for symptoms to start going away.
Per RN  report: patient  received dose 1 of the Moderna COVID vaccine (lot 041B21A, exp 5/6/2021) at 1023. At 1025, EMT shouted across the room to RN  "she's going to faint." RN  approached patient to assess, the patient was diaphoretic, pale, and not responding to questions or making eye contact. RN  squeezed her hand and patient made eye contact and verbalized feeling lightheaded. RN , EMT , and EMT  transferred the patient to a zero-gravity chair allowing patient to recline. RN returned from helping outside and approached to assist at RN  was taking care of another patient. At 1027, patient reported feeling faint, sweaty, with blurry vision, and ringing in the ears. Vital signs: 94/62, pulse 72, O2 93, respirations 22. Patient denied nausea, reported she had eaten breakfast that morning. Patient reported having a similar reaction when she donated blood previously. Patient denied allergies, medical conditions, or taking any medications. At 1035, vital signs: O2 99%, pulse 68, blood pressure 104/62, respirations 22. PHN  offered Benadryl but patient declined. PHN  encouraged patient to contact provider and when to call 911. At 1042, vital signs: blood pressure 98/62, O2 99%, pulse 74, respirations 22. Patient reported that she was experiencing numbness in both hands. At 1049, patient reported her symptoms were improving including the numbness in her hands, blurry vision, and lightheadedness. Patient reported feeling cold, weak, and shaky. PHN  noted patient's facial color was returning. At 1054, vital signs: blood pressure 100/62, O2 99%, pulse 68, respirations 20. Patient reported her symptoms has resolved at this point. At 1059, vital signs: O2 99%, pulse 69, respirations 18, blood pressure 110/64. PHN  and EMT  assisted patient to seated position. At 1105, patient stood up with PHN  and EMT  close by. Patient reported no symptoms and back to her baseline. At 1108, EMT  walked patient out. Patient left walking with steady gait.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single at the age of 55 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (12Sep2023) positive, notes: Rebound positive text on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine and medication in two weeks. Paxlovid was taken as treatment for COVID-19 from 02Sep2023 to 07Sep2023.  No follow-up attempts are possible. No further information is expected.
anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient mother). A 36-years-old female patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization (Vaccinated at 36 years age). Patient medical history and concomitant medications were not reported. Patient's mother reported that her daughter received the first dose of the Pfizer covid vaccine and had an anaphylactic reaction on an unspecified date in Mar2021 and she was concerned and wanted to know information about her walking around not being fully vaccinated and with the delta variant. She would like to know how protected was her daughter after receiving one dose of the vaccine and to the variant. She wanted to know if there is a pathway for full vaccination with the Pfizer covid vaccine after someone had an anaphylactic reaction to the first dose. She stated under a hospital setting is there a clinical study to support administering a smaller amount. Stated that she talked to (withheld) and thought there would be a study regarding this but she understands that not a lot of people had an anaphylactic reaction to the vaccine. On follow-up on 13Jul2021 she reported that anaphylaxis shock was confirmed by the doctor and she was fine. Patient mother was wondering if there are any other clinical trials. Her daughter was walking around half vaccinated and she was concerned. Patient was taken to a research hospital and they handled the report at hand and verified her adverse event, did not clarified if daughter was actually hospitalized. No further details provided. The outcome for the event was reported as unknown.  Information on lot/batch number has been requested. Further Information was expected.
Pain in lower back, Severe discomfort, achy. Heavy breathing to control pain. Fever don't recall. Contact Dr. 's PAs. They did a few tests on me. Symptoms subsided shortly after leaving Drs.
Round red hard swelling at injection site about 2 inches still present at 48 hrs, no itching Slight soreness in left arm, almost gone at 48 hrs
Injection Site Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 SITE PAIN (Injection Site Soreness). At the time of the report, VACCINATION SITE PAIN (Injection Site Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Right deltoid reaction to DTaP 17 cm long x 17 cm width, no fever. Treatment Benadryl & Tylenol.
Symptoms of tightness of chest began about 1 to 1 1/2 hours after vaccination given.Went to ED, O2Sat 80, received epi, solumedral and benydral.
Patient developed an erythematous, pruritic cutaneous rash on her arms and legs twenty four hours after vaccine administration.  Patient was treated with benadryl.