chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Moderna vaccine against COVID on 2/15/2021 and 1/28/21 (lot number 037k20a).   Vaccinated at a site but immunization in state database.   Presented with shortness of breath and weakness in lower extremities.  No requirement for supplemental oxygen.  Treated with PT/OT.   Shortness of breath resolved.
Suspected vaccination failure / first injection on 5/25/18, and second injection on 9/14/18, and experienced shingles; shingles on back; muscle pain on back / back pain; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2018, the patient received the 1st dose of Shingrix. On 14th September 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 25th January 2020, 610 days after receiving Shingrix and 498 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and muscular back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and muscular back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and muscular back pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient received 2nd dose of vaccine in unknown arm. The patient had the Shingrix series and experienced shingles on her back. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles was not provided. The reporter consented to follow up.
walks with a can; numbness in her hands and feet; weakness in her legs; 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 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 15:00 (Lot number: EW0151) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1ST DOSE, First dose: 27Aug2021, Lot number: FD8448), administration date: 27Aug2021, when the patient was 74 years old. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "numbness in her hands and feet"; MUSCULAR WEAKNESS (non-serious) with onset Sep2021, outcome "not recovered", described as "weakness in her legs"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "walks with a can". The events "numbness in her hands and feet", "weakness in her legs", "walks with a can" and "numbness in her hands and feet" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia, muscular weakness, gait disturbance, hypoaesthesia.  Additional information: Event: Her symptoms started the week after her second dose in Sep2021. She did her research and started taking Vitamin D3 and B12. She is walking with a cane due to the weakness in her legs. Her left arm and hand is the worst. She has no numbness in her right arm, just the hand.  No follow-up attempts are possible. No further information is expected.
Patient received his first Moderna vaccine. He began feeling very lightheaded after the vaccine was given. Staff gave him an ice pack to cool down his head, and alerted other staff to the issue. Staff offered the patient a paper bag to breathe into, but he refused. He decided he wanted to lay down and elevate his feet. As soon as he stood up, he got more lightheaded. He ended up passing out. Staff guided him into a chair, making sure he did not hit his head. He was unconscious for about 20-30 seconds. Staff rubbed his arm vigorously and spoke loudly to him to wake him up. Once awake, he immediately threw up. Staff then made sure he was oriented to person and place. Staff sent another member to get him some cold ice water. Staff stayed with him while he was recovering the whole time. By the time the patient decided to go, he was feeling very well. An electronic shopping cart was retrieved for him, but he refused.
Information has been received from a registered nurse concerning an 8 year old female with no allergies or medical history who on 5/2/97 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 5/29/04, the patient experienced one spot or pox on her stomach. She had more spots the next day and some were red and others were red with white pinpoint scabs. More pox were noted on 6/1/04 with a total of approximately 200 eruptions or pox. Unspecified medical attention was sought and she was treated with acetaminophen and diphenhydramine hydrochloride cream. The nurse also suggested diphenhydramine hydrochloride for treatment. A product quality complaint was not involved. Follow up information was received from the registered nurse who indicated that on the evening of 5/29/04, the patient's mother called the reporter's office and asked when she could send the patient back to school. It was noted that her usual physician was out of the office. The patient had hundred of red bumps but only about 150 blistered and then not too severely. It was noted that chicken pox was going around her school at that time. The patient was sent back to school with scabs on 6/4/04. Subsequently, the patient recovered in mid June 2004. No diagnostic laboratory tests were performed as the patient was not seen by her medical provided. Neither the patient nor her sibling had any adverse events following prior vaccinatino. No further information is expected.
may or may not have latex allergy; Patient may or may not have latex allergy; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy (possibly).   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and documented hypersensitivity to administered product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details reported were as follows: The age at vaccination was not reported. The patient may or may not had latex allergy and patient received Boostrix in 2015 or 2016, which led to circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. The healthcare professional gave permission for follow up. This case was linked with US2022050444, US2022AMR051880 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022050444:Same reporter. US-GLAXOSMITHKLINE-US2022AMR051880:Same reporter.
Felt tachycardia  BP 120/80 HR 120   Laid supine and monitored  for 30 mins.  Resolved. Repeat BP 118/78   HR 84
Case number PHEH2015US020294 is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 60 years old male patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
Dizziness approximately 10 minutes after vaccination. Patient fully recovered after ~ 15 minutes. Normal B.P.
my breathing started to get heavy, felt it hard to breathe; I started to develop large hives just above the collar bone; pain in the lymph nodes under her left arm; started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and; little pain at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) and ANGIOEDEMA (I started to develop large hives just above the collar bone) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE (FLOVENT HFA).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (little pain at the injection site). On 05-Apr-2021, the patient experienced DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) (seriousness criterion medically significant), ANGIOEDEMA (I started to develop large hives just above the collar bone) (seriousness criterion medically significant), VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and). On 05-Apr-2021, VACCINATION SITE PAIN (little pain at the injection site) had resolved. At the time of the report, DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe), ANGIOEDEMA (I started to develop large hives just above the collar bone) and VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) outcome was unknown and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Patient had syncope, dizziness, vaso-vagal response, lightheadedness, pale, mild hypotension. Given juice, laid down, vitals stabilized, ambulated appropriately. Released from vaccination site.
Feeling kind of sluggish; little bit achy; body ache; Had severe temperature 100 degree; Pounding headache; my cheeks bones, my teeth was hurting; my cheeks bones, my teeth was hurting; Lost my appetite; Nausea; Couldn't sleep; My head it was squished; I felt I have fever; little bit achy and during the night it got worse; Energy wise I am not 100%; I was still feeling bad; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: unknown) via intramuscular route, in left arm on 07Mar20201 (age at vaccination: 70-years), as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route, on 14Feb2021 (age at vaccination: 70-years) as dose 1, single for covid -19 immunisation, and experienced little bit soreness at the injection site. Patients medical history and concomitant medications were not reported. After vaccination, by the end of the day patient was feeling kind of sluggish, little bit achy and during the night it got worse. She had severe temperature 100 degree, headache, did not take any Tylenol or anything because wanted the COVID vaccination to take action. Patient was a mother of 2 Pharmacist children, so in the morning temperature was 99.5, was still feeling bad, severe headache, pounding headache, cheeks bones, teeth was hurting so she took Tylenol (Treatment) and it started getting better. It took it 2 days after the vaccination to feel little better. Patient lost appetite, had severe nausea also after that for the next day was okay but then again started feeling nausea, severe nausea, lost my appetite and then during that time did not take any medication and during the night again got temperature, couldn't sleep, in her head it was squished, cheeks bones were hurting, it was really bad in the morning and felt she had fever, the body ache and feverish but the temp was 96.1. Patient felt feverish though, again laid down and do not remember if she took the half dose like 337 mg of Tylenol because she had the 8 hours extended relief (Clarification unknown), she said she does not want to take that strong, so took half of that, her body ache was better and now body ache was gone, little bit headache but still had nausea. Patient wanted to know for how long these symptoms will last? As treatment patient took the half dose like 337 mg of Tylenol tablet, orally once and had 8 hours extended relief (clarification unknown), took half of that, her body ache was better. The first vaccination patient was okay had no problem, just little bit soreness at the injection site but these events were after the second dose. Just nausea and headache. Energy wise patient was not 100%, a bit sluggish but her energy level was not the same. The outcome of events for little bit achy; body ache, was recovering for pounding headache, nausea, not recovered, and for rest it was unknown.   No follow-up attempts are possible. No further information is expected.
sleepy and unresponsive; sleepy and unresponsive; spots on his back and hives on his abdomen; stomach pain; vomited; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient had no  pertinent medical history. Drug reactions/allergies included fish allergies. Concomitant vaccine included diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).   On 06-JAN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (subcutaneous, lot# was reported as reported S017238, expiration date 01-DEC-2020; dose detail was unknown) for prophylaxis.   On the same day, the patient began to complain of stomach pain and vomited while still in the physician's office. After examination, the patient had spots on his back and hives on his abdomen. The patient was administered diphenhydramine hydrochloride (BENADRYL). Then the patient became sleepy and unresponsive. The patient was taken to an unspecified hospital, where he was admitted and given glucocorticoids (PREDNISONE). On the same day, the patient was discharged. The patient didn't perform the lab diagnostics. The outcome of events was reported as recovered on 06-JAN-2020. The causality between events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
On going severe arm pain, after FLU  injection was given very high on left arm. Pain continues despite physical therapy.
Imm. given 02/27/2003. On 02/28/2003 at 6pm child developed a rash around DTaP site in left arm with whittish center, rash spread to under arm back and 1/2 child's neck. Mother called local ER, Benadryl advised and was given by mother. 03/02/2003 child developed hives over his body. To ER per father, injection given. Mother called HD 03/03/2003 to report incident. Rash was gone at this time.
Fever 100.5; myalgia; headache; nausea; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 11Jan2021 19:00, the patient experienced fever 100.5, myalgia, headache and nausea. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Patient states that an hour to 1.5 hours after vaccine she feel tingling in her jaw then numbness then her arm followed by her leg. It only lasted a short time frame and then back to normal (could not give exact time)
chills for about an hour around 11pm, continued on and off for about 15 more hours. Body aches for about 15 hours, headache on and off for about 15 hours.
an expired dose of Shingrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received Herpes zoster (Shingrix) (expiry date 12-OCT-2023) for prophylaxis.   On 25-OCT-2023, the patient received Shingrix. On 25-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Shingrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date - 25-OCT-2023 The pharmacy intern reported that an expired dose of Shingrix was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
received an unspecified number of "booster shots of a hepatitis A vaccine"; No adverse effects reported; This spontaneous report was received from a physician of unknown age and gender, via company representative, referring to him/herself. Patient's medical history, concurrent conditions or concomitant medications, were not reported.  It was reported that on unspecified dates, the patient may have received an unspecified number of "booster shots of a hepatitis A vaccine" (manufacturer unknown) (Extra dose administered) (strength, dose, route of administration, lot number and expiration date were not reported). No adverse effects reported.
Passed away; so weak she was no longer able to use her walker and declined steadily each daythereafter; A spontaneous report was received from a consumer concerning a 88-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being so weak she was no longer able to use her walker and declined steadily each day thereafter (asthenia) and passed away (death).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date.  On an unspecified date, approximately 15 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified date, two days after their second dose of the vaccine, the patient was so weak that she was no longer able to use her walker and declined steadily each day thereafter. On an unspecified date, 17 days after their second dose of the vaccine, the patient passed away.   Treatment information was not provided.    The outcome of the event, asthenia, was unknown. The outcome of the event, passed away (death), was fatal. The cause of death was reported as unknown. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
I did not feel very well after neither of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine). At the time of the report, VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-233532 (Patient Link).
Initial information has been received from a registered nurse concerning an adult with an unspecified age, pertinent medical history or drug reactions/allergies who was not on dialysis. On an unspecified date, the patient was vaccinated with the first dose of RECOMBIVAX HB and it was the adult formulation, (lot number and exp date were not reported). On an unspecified date, the patient was vaccinated intramuscularly with second dose, dialysis dose, of RECOMBIVAX HB (lot #0276AE and exp date 27-MAR-2013) 40 micrograms. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. The patient's outcome was unknown. Additional information is not expected.
I got the COVID booster on 10/8/21 at 12 pm. I had a vagal response, which is normal for me. Staff responded appropriately and I was fine. I stayed for approximately 15 minutes. I left and within 5-10 minutes of driving home I began to feel my lips, hands, and face tingle, I felt very hot, and my tongue felt full in my mouth. I got home in about 30 minutes. I took 25 mg of Benadryl. I still did not feel better, so I went to the. They gave me a round of Epinephrine and called 911. Paramedics noticed audible wheezing, SpO2 was decreased, but still above 92%. They gave me a breathing treatment, along with IV 25 Benadryl. Once I got to the hospital, I was fine. I no longer had wheezing. I was sent home with a prescription of Epinephrine (2 injectors) and Prednisone for 3 days. I had no symptoms since. My home medications include Keppra 1,500 BID, metoprolol 25 XR BID, Nexplanon implant RA, and Amoxicillin (for current ear infection).
PAIN FROM THE SITE OF THE SHOT TO MY NECK.   14 DAYS AND STILL PAINFUL..........MAYBE HIT A NERVE. WENT TO DR. AND TO EMERGENCY ROOM. ON MEDICATION AND ANTIBIOTICS...........