chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shivering, extreme muscle ache in entire body; ankles, knees, hips, arms, shoulders, difficulty walking 3-4 hours. Redness in arm where vaccine was given with soreness for 3-4 days. Stomach pain, nausea, headache, shortness of breath and sore throat for approximately 24-36 hours. This was the second vaccine and I had the same symptoms with the first without the shortness of breath, so I knew it would eventually go away. I received the first vaccine on October 19, 2018 at the same Pharmacy.
Patient got shot on 05/20/21, waited in the pharmacy for 15 mins and felt fine.  Patients mom called after about an hour and said patient fainted but recovered soon.  He was not hurt,  mom was advised to keep an eye on patient and call 911/ or urgent care visit. Per mom will wait.  Called patient after some hrs per patient he is fine and has no adverse symptoms anymore.
Patient called the pharmacy on 01/04/19 and stated that she possible had an allergic reaction to the vaccine she stated that her arm was warm developed a red rash as well as a small bump around the site of injection a some further down the arm. I told the patient to keep an eye on the rash and to take 1-2 BENADRYL every 4-6 hours until the rash resolved. If the rash got worse or continued to spread I told her to go to urgent care or the ER immediately
Our Son got the shot for Shingles and has shingles now/ Suspected vaccination failure; Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Our Son got the shot for Shingles and has shingles now/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient's parent via interactive digital media. The reporter reported that his or her son received Shingles vaccine and experienced shingles now. The reporter stated that it was painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
The patient was administered a 4th dose of GARDASIL 9; No additional adverse event; This spontaneous report was received from a nurse via a company representative referring to a 19 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On unknown dates, the patient completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (strength, dose, route, lot # and expiration date were not reported) at medical practice for prophylaxis.         On an unknown date, the patient was administered a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(strength, dose, route, lot # and expiration date were not reported)(extra dose administered) because there was no record of his vaccination history. No additional adverse event was reported.
Received vaccine Friday late morning. Arm was sore by Friday evening. Saturday morning awoke with slight fever, malaise, and extremely sore arm. Both sore to the touch and painful to move. Sunday morning awoke with arm swelling and redness. Swollen area feels hard and warm to the touch. About the size of the palm of an adult hand. While not centered on the location of injection, there is overlap. Report is filed Monday - arm is still red, swollen, warm to the touch, and painful to touch. It is now only slightly painful to move the arm. Note: patient does not recall having any visible reaction to a vaccine prior to this one. This was the second shot; the first only made the arm sore, much like a flu vaccine might do.
Approx 20 min after receiving injections, pt c/o feeling dizzy. No SOB no diaphoresis, however, status change noted. Pt unable to answer questions. No LOC. Hypersensitive to touch on arms. EMS called. BP 118/68. Glucose 73. Pt c/o feeling cold and shaking/shivering observed. Transported to Emergency Room via ambulance 30 min after injections given.
Patient complains of severe body aches, runny nose and upset stomach since time of vaccination. (>2weeks).
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month old male patient who received INFANRIX (batch number Y5475m expiry date unknown). This case was associated with a product complaint. On 23rd April 2018, the patient received INFANRIX. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema and generalized rash to be related to INFANRIX. Additional details were provided as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 to 18 month visit. The patient's mother stated earlier the week of 5th May 2018, that the rash was till there and thought it was possible due to an allergy to ranch dressing. According to the treating physician the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTAP. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return the one vial from the lot for investigation. The reported agreed to contact on follow up. This case has been linked with case US2018GSK080169 and US2018GSK080192, reported by the same reporter.
Information has been received form a registered nurse concerning a 12 year old female with ZITHROMAX allergy (total body swelling) and no illness at the time of vaccination who on 10-NOV-1997 was vaccinated with the first dose of VARIVAX vaccine (Oka/Merck) (route nor reported). On 18-JUL-2008 the patient was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck) (lot number 659612/1655U) (route not reported) into the right triceps. On 27-OCT-2008 the patient developed some spots on stomach and on the back of both legs. The patient had a headache and no fever. The patient was diagnosed with varicella. On 03-NOV-2008, the patient recovered from varicella. Additional information is not expected.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case contains information for the 10 out of 16 adult patients described by the reporter. No concomitant information was reported. Reporter states, "16 Patients Vaccination Cards reflects the wrong lot numbers and cannot figure out which patient's records are wrong. All patients received the correct vaccine and bivalent dose. The error only involves documentation. They administered Bivalent boosters from Bivalent Lot numbers: 061F22A and AS7170B. They wrote AS7170B on all 26 patient's vaccination cards. Cannot distinguish which patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:Master
Information has been received from a registered nurse concerning a 30 year old female with acne who on 25-SEP-2006 was first vaccinated IM with 0.5 ml of Gardasil (lot# 654741/0013U). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 25-SEP-2006 the patient experienced increased acne. On 25-NOV-2006, the patient received her second dose of Gardasil. Her acne became progressively worse. On 12-MAR-2007, the patient was vaccinated with the third dose of Gardasil. On 12-MAR-2007, she experienced severe anxiety. It was noted that the patient's acne was related to Gardasil. No treatment or lab testing was provided. Subsequently, the patient had not recovered from increased acne. The patient's severe anxiety resolved in 24 hours. Additional information has been requested. The registered nurse reported that 3 other patients' experiences after Gardasil administration (WAES 0703USA02840, WAES 0703USA02797, WAES0703USA02815).
Patient recieved first dose of the shingrix vaccine on 10/15/19 had low dose fever, body aches, and nausea post injection but was fine after 24 hours. After second dose, patient started have left side pain (kidney area and to lower back) one week after the  second dose. She went to PCP with elevated blood pressure, and thought she may be dehydrated. PCP gave ok to go home, and patient tried to eat and drink something which helped a little. She took a nap and woke up feeling worse, and PCP directed her to go to ER. At ER, EKG looked fine, but did a CT with contrast and found the renal infarction. She was admitted. There they did another EKG, chest Xray, and CT with contrast. Was given pain meds in hospital and lovenox inj. was discharged 5 days later with follow up with vascular specialist and now on coumadin. Again, could be coincidence with factor V leiden disorder but thought it was imporant to report.
(R) arm injection site swelling and redness, pain, hot feeling, sweating, wheezing.
Body aches, chills, fatigue, throbbing at injection site. My symptoms got progressively worse in the evening. I was barely able to move from my bed that night to go to the restroom because I was so weak. I slept 11 hours that night. The next morning I felt better.
Received vaccines 4/27/07. Starting 4/27/07 had redness, swelling and warmth at injection site right arm. Redness persists as well as warmth and itching, No hives, swelling resolved.
Pt recvd booster dose of MMR on 23AUG90; 15 min following vax devel giant urticaria & difficulty breathing due to congested nose & swollen & itchy eyes caused by angioedema; tx Epi & DPH;
seizure; patient missed second dose appointment due to hospitalization; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date, which required hospitalization. It was also reported that the patient missed second dose appointment due to hospitalization on an unspecified date. The patient reported that she received first dose before the hospitalization. The clinical outcome of seizure and patient missed second dose appointment due to hospitalization was unknown. The reporter (patient) assessed the causality between the event and BNT162B2 as unrelated (reported as: nothing to do with seizure).  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on an implied chronological connection to the vaccine, a causal relationship between event seizure and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient has history of ToF. The patient has been doing very well on Inderal until he received his immunization booster. Shortly after his shots, he developed fever and cyanosis. He did not sleep and was irritable. The next day he saw his cardiologist. Consequently underwent ToF repair. Surgery was complicated by subacute hypoxic ischemic infarcts leaving him quite debilitated. The 60 day follow-up states that the pt remains significantly retarded. Currently enrolled in speech, occupational and physical therapy program. Feeding has been challenging and G tube placement. He is followed by many specialists including a cardiologyst, neurologist and gastroenterologist. Annual follow up states significantly retarded. Receives treatment at hospital.
No additional adverse events; Caller is medical assistant requesting four doses administered of improperly stored MMR II.; This spontaneous report has been received from a medical assistant, referring to a 12-month-old patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 27-JUL-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (recombinant human albumin rHA) (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot number U023829 has been verified to be a valid lot number, expiry date 30-JUL-2023) (strength, dose, frequency, and route of administration were not provided) as prophylaxis.  The measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) wsa stored at a temperature of 10.1 degree Celsius (C) for a time frame of 15 minutes. There was no previous temperature excursion.  No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003406:
Vertigo and dizziness this friday; Vertigo and dizziness this friday; slight unsteady on feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN, Batch/lot number: Unknown), for COVID-19 Immunisation. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 18Mar2021, outcome "unknown", described as "slight unsteady on feet"; VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 19Mar2021, outcome "unknown" and all described as "Vertigo and dizziness this friday".  Additional information: Verbatim and event description: Patient stated she got her 2nd dose last week Saturday (13Mar2021) and this Thursday (18Mar2021) she experienced slight unsteady on feet, vertigo and dizziness this Friday (19Mar2021). Asked if she can take medication and asking how long will the vaccine will cause these side effects such as dizziness (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Fever, shivering, exhaustion, extreme pain at injection site. This lasted for about three days.
I have developed chronic idiopathic urticaria (hives) and dermatographia.  I can't be entirely sure that this condition has stemmed from the vaccine.  I only know that I'd never had chronic hives before I got the vaccine, so I figure it was worth reporting.  I manage this through Zyrtec (antihistamine) on a daily basis - I can't function without it.
Information has been received from a registered nurse concerning a 2 year old female who on 22-FEB-2007 was vaccinated intramuscularly with 0.5 mL varicella virus live (Oka/Merck) (Lot # 653307/0439F). The patient received the first dose of varicella virus vaccine live (Oka/Merck) IM instead of subcutaneously. The patient's mother reported that the patient developed redness on the belly, back and arms the afternoon after the vaccination with varicella virus live (Oka/Merck). The patient was lethargic that night and had a fever of 100 degrees Fahrenheit.  The mother was advised to give the patient therapy with diphenhydramine hydrochloride (BENADRYL). No lab diagnostic studies were performed. On 23-FEB-2007 the patient was reported to be "much better," but the condition of the redness was unknown (also reported patient had not recovered). Additional information has been requested.
This case was reported by a physician and described the occurrence of an injection site reaction in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date, the patient received "the 2nd or 3rd" dose of Infanrix. At an unspecified time post-immunization, the patient developed an injection site reaction characterized by swelling and redness. As of 29 August 2003, the outcome of the event was unknown.
Since vaccination patient has been treated in office for swollen lymph nodes, shingles and  DVT right lower extremity
After the vaccine was administered patient became visibly distressed during the 15 minute observation period. Vital signs show hypotension BP 70/44, HR 51 and SPO2 Sat 100%. Vaccination area management notified, clinic rapid response team was called upon, and patient was taken to the PAA area of the clinic for an evaluation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney cancer" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "high BP" (unspecified if ongoing); "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 02Nov2019; NOVOLOG, start date: 02Nov2019; TRETIVA, start date: 02Nov2019. The following information was reported: DRUG INEFFECTIVE (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: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications were received in 2weeks. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date was 04Dec2022, treatment stop date was 09Dec2022, indication was Treatment of COVID-19. Other medications in 2 weeks include Levothyroxin, Novolog, Trexiva, Heat meds, start date 02Nov2019. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine given 1 day past the 30day limit for being kept in the refrigerator. Unknown if any issues with patient none reported to office.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: