chrisvoncsefalvay/vaers-outcomes huggingface dataset:
finger tips were numb; "can't sleep"/ she couldn't sleep; flu-like symptoms; fever twice 101.8; muscle aches; queasy/queasiness; teeth chattering; Sweating (diaphoretic); This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis. Concomitant products included meloxicam.   On 9th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th September 2022, 1 days after receiving Shingrix, the patient experienced fever, muscle pain and queasy. On 11th September 2022, the patient experienced numbness in fingers, sleeplessness and influenza-like symptoms. In September 2022, the patient experienced teeth chattering and sweating. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, teeth chattering, muscle pain, queasy, numbness in fingers, sweating, sleeplessness and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The patient reports she received 2nd dose on left arm.  She stated that on the next day, she had experienced a fever (twice) 101.8 degree Fahrenheit, muscle aches, queasiness.  Two days after receiving vaccination, she stated she could not sleep, had flu-like symptoms and finger tips were numb.  She had gone to urgent care, tested negative for COVID, and was recommended to take tylenol and Ibuprofen.  She had mentioned that she was also on Meloxicam for her arthritis.  She had read about Guillain-Barre syndrome and had decided to call GlaxoSmithKline (GSK). The reporter had consented to follow-up. Additional supportive information: The time taken to onset for event - Teeth chattering, Sweating was conservatively captured as Less than a week and for event - numbness in fingers, sleeplessness and influenza-like symptoms was captured as 2 days. The temperature for fever was also considered as degree Fahrenheit conservatively as per the reported verbatim.
The patient experienced severe pain, swelling, tissue damage at the site of injection, requiring medical intervention. The symptoms of pain started at the time immediately following the injection, and she is still experiencing it to this day.
30 mins after vaccination patients was driving and foot slammed on gas pedal. Patient began to have severe back pain, leg pain, pain in uterus, fatigue, nausea, bruising on legs, headaches. brain fog, gut issues.
pt recv vax 19FEB96 & on 18FEB97 pt exp chicken pox w/less than 50 lesions;
Pt had severe fever and chills. She was also very nauseated and unable to eat. Her arm is very sore. The symptoms resolved within 24 hours, except for the sore arm.
Looked weak immediately following vaccine in (L) deltoid. Mom said "I think she's going down" - caught her. Eyes rolled to upper corner of sockets briefly within 5- seconds ->had fully recovered. Pt reported feeling "dazed" and shook (arm tremor mild) briefly . Pt was seated then -> had water to drink and lollipop (+ coordination). Pt denied rash, itching, dyspnea. Sat X 10 mins, walked around store -> reported feeling "back to normal".
No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills which I read is normal but I noticed tingling in my legs. And a cold sensation. No weakness and it resolved in about an hour.  Then today 1/1/2021 numbness and tingling/pins and needles in my feet and legs . It lasted a few hours and mostly resolved. I was not sure if there was a possibility of guillian barre occurring post this .
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Swelling (2cm), redness (1cm). Swelling occurred at Prevnar injection site.
Patient received second dose of Covid 19 vaccine at 10:15am. Patient was asked to wait 15 minutes and report any adverse events. She stated she was experiencing blurry vision. Patient was asked to wait another 15 minutes and then she stated she was ok to return home. Called to check on patient at home. Patient stated she still had blurry vision
Fever, pain, limb swelling started within 16 hours of injection. Patient taking ibuprofen for pain and swelling.
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving  the 7 day. Pharmacy policy was to follow the expiration of 5 days.
PATIENT WAS NOT 18 YEARS OLD WHEN VACCINATED. MODERNA AGE INDICATION IS 18 YEARS OLD AND OLDER.
Sick; She was soak; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HYPERHIDROSIS (She was soak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (ATORVASTIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE BESYLATE and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced ILLNESS (Sick) and HYPERHIDROSIS (She was soak). At the time of the report, ILLNESS (Sick), HYPERHIDROSIS (She was soak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included, ibuprofen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow up information was received on 30 Mar 2021; included,  patient reported that she do not have a primary doctor he retired.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Itching, Rash, Soreness and aching of joints plus muscles in arms and legs, increase of numbness in both legs aggravating already arthritic spinal surgery resulting condition
A few hours after injection, pain and swelling at the injection site (far upper right arm)  lasting about 1 week. On approx. day 2 post injection, began experiencing pain and limited range of motion of my left shoulder.
Pt developed a cellulitis to site of injection measuring 7-8cm in diameter - (L) arm (deltoid) started on BACTRIM DS 1 twice a day x 10 days.
Patient presented to this facility on 5/12/21 as transfer from hospital for treatment of acute hypoxic respiratory failure secondary to COVID pneumonia requiring intensive care unit treatment.  Patient did receive a J&J COVID vaccine on 4/7/21.  Patient was intubated on arrival.  Patient was treated with remdesivir, tocilizumab, steroids, and antibiotics.  Patient's ARDS progressed.  He developed septic shock, recurrent pneumothoraces, and acute kidney injury on chronic kidney disease.  Patient did not improve.  Patient was transitioned to comfort care on 5/23/21 and patient expired.
Area of redness -> 6" x 4" (R) thigh at site of vaccine with local temp increased.
after receiving their second dose, they felt itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (after receiving their second dose, they felt itchy all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043l20a and 025l20) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (after receiving their second dose, they felt itchy all over). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (after receiving their second dose, they felt itchy all over) outcome was unknown.            This case was linked to MOD-2021-300374 (Patient Link).
Received moderna booster and only had a sore arm at injection site the rest of the 1st day.  Had a hard time sleeping because of sore arm and got up about 3 times to use restroom which is very unusual for me.  I usually don?t have to use restroom during the night.  The next morning, upon getting out of bed, I felt very dizzy and lightheaded.  I made it to the table and soon after fainted.  My husband was sitting on the side of me and tried to hold me up from falling on the floor.  If he was not present, I would have fallen.  While holding me up, he tried to call 911, but the phone was in his pocket closest to me and could not get it out of his pocket.  He said my eyes and mouth were wide open and I was grasping for air pretty heavily.  He slapped my face a couple of times to get me to respond.  I do not remember anything that happened.  He walked me to the bed and I began to feel very sweaty and hot.  I was given a cold facecloth to help cool me.  As the day progressed, I became stronger and was able to eat.
Extreme fatigue; light headed; room spinning; feels like bugs crawling under skin; vomiting lasting 3 days; This is a spontaneous report from a contactable consumer (reported for herself). The non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration as a single dose on 30Mar2021 02:45 PM, for Covid-19 immunization. Medical history and concomitant medications were not reported. She did not have known allergies. She received first dose BNT162B2, Lot number: unknown) via an unspecified route of administration as a single dose on an unknown date, for Covid-19 immunization. On an unknown date, the patient experienced extreme fatigue, felt lightheaded, room spinning felt like bugs crawling under skin and vomiting lasting 3days. She did not receive treatment for events. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 Since the vaccination. The outcome of the events of extreme fatigue, felt lightheaded, room spinning felt like bugs crawling under skin and vomiting lasting for 3 days was recovering. No follow-up attempts were needed. No further information was expected. Information about lot/batch number could not be obtained.
Immediately following vaccine administration, patient's face and trunk became flushed and she complained of nausea and feeling faint. No difficulty breathing. BP was measured as 77/45, HR 80, RR 22. EMS on site administered IV fluids, Benadryl and Zofran. Patient remained hypotensive and symptomatic after 30 minutes, so was transferred by ambulance to the nearest emergency room. She was reportedly treated in the ED and discharged home.
It was reported that a 62 year old male received Fluzone SV '99-'00 on 10/13/99. The pt experienced myalgia in his fingers. No further information is available at this time. Information received on 11/22/99, provided pt's information, time of vaccination and pre-existing conditions. The pt reportedly recovered from this experience.
10 patients were administered an expired dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (10 patients were administered an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up document contains No New Information On 04-Nov-2021: Significant follow-up( Reporter added-HCP, events added, PT details added)
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/22/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 10/22/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Tired after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-May-2021 and was forwarded to Moderna on 31-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after first dose) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired after first dose). At the time of the report, FATIGUE (Tired after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This case was reported by a physician to a sales rep and described the occurrence of an injection site reaction in a pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The physician reported that she was seeing more pt's with injection site reactions following the admin of Pediarix however no pt identifiers were provided. On an unspecified date, the pt received a dose of Pediarix (dose # not provided). At an unspecified time following the admin of Pediarix, on an unspecified date, the pt experienced a local injection site reaction. The physician stated that she believes she is seeing more injection site reactions after switching to Pediarix versus monovalent vaccines. The outcome of the injection site reaction was not reported.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Medium, Error: Patient Too Young for Vaccine Administered-, Additional Details: Pt's Mother had given wrong date of birth. Pt was too young but with the date of birth of 2008 which was given by mom. She was old enough for the regular dose
Had fever and redness around site, body aches. Noticed redness 7/11/18.
Info has been received from a licensed practical nurse concerning a 28-year-old female pt who on 11/06/2002 in the AM was vaccinated SQ in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642720/0172M). It was reported that there was no illness at the time of vaccination. Subsequently, the pt developed swelling and tenderness at the site of the injection. The report also indicated that the site was painful and warm, with approx 3 cm by 3 cm induration. Unspecified medical attention was sought. Additional info has been requested.
left arm hurts a lot; feels strange; pain in the bones; doesn't want to wake up; headaches; 1st dose on 22Nov2021, 2nd dose 2Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015F21A and 940877) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22Nov2021, 2nd dose 2Feb2022) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm hurts a lot), FEELING ABNORMAL (feels strange), BONE PAIN (pain in the bones), DECREASED ACTIVITY (doesn't want to wake up) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Body temperature: normal (normal) normal.         Concomitant medications were not reported.   Event onset of symptoms will be in Feb 2022.  Patient got the second dose in her left arm and told to caregiver that  that her arm hurt a lot, she felt strange and had headaches, pain in the bones, did not want to wake up and her temperature was normal.
Fever 102.8 day after receiving H1N1 flu vaccine inj. with body aches and cough.
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: sewlling and join pain-Medium, Systemic: Weakness-Medium, Additional Details: Pt called today 09/29/2021 about AE to vaccine. She has been expereincing swelling in her hands and feet. gernalized pain on back and all over body. joint pain as well. Has been lasting since saturday. Does not have a PCP but advised her to find one or f/u with Phjysciian that knows her best. Pt will keep us updated and will f/u with provider.
blisters on the inside of her fingers on both hand; red blotches all over her body; redness at the site of injection; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 99SE3, expiry date 30th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (injection). On 19th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and pruritus. On 20th October 2020, the patient experienced blister and red blotches. On an unknown date, the outcome of the injection site erythema and pruritus were recovered/resolved and the outcome of the blister and red blotches were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pruritus, blister and red blotches to be related to Shingrix.  Additional details were reported as follows: This case was reported by the health care professional. The patient received the 1st dose of Shingrix injection and complained of red blotches all over body, itching, blister on the inside of fingers on both hands and redness at the site of injection. The health care professional wanted to know if the blotches and blisters on the fingers were normal occurrences. The reporter consented to follow up.
Hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 10:15 (Lot number: 320308D) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed 6-7 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no=1 at 18:30 , Lot FF2589,, Injected in left arm in the muscle), administration date: 01Oct2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "recovering", described as "Hair loss".  Additional Information: Warm transfer from (Name withheld), Support, 159558 She has a consumer on the line who just received Series from Pfizer in Oct2021 and since then has noticed hair loss.Patient confirmed information above. She works in the medical field, but is not a healthcare professional. She received her first dose on 01Oct2021, which was a Friday, and by Monday or Tuesday, she realized her hair was coming out quite a bit and for the next 2-3 weeks, she was losing a lot of hair.She never had a hair problem before.It did not dawn on her until she talked to a friend last night.It was embarrassing and she looked it up online and saw articles where a few patients had hair loss with it. Since she noticed it at first, over 2-3 weeks, it was more and more, but now it has slowed down a bit.She thought that it was due to getting the shot and it does lower your immune and didn't know if that were it. She did look at the vaccine before he gave it to her, even though she is not a nurse. The second dose of the Pfizer COVID vaccine was last Saturday.By then, she had considerably less hair on her head.She provided lot 320308D, Expiration unknown. Date was 23Oct2021, and it was injected in right arm in the muscle. She got it for her job and she wants to travel and have no restrictions for travel. She did not wish to provide her primary care doctor's name or contact details. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Any AE(s) require a visit to Emergency Room and Physician Office reported as No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as none. Patient's Medical History (including any illness at time of vaccination) reported as None or Unknown Family Medical History Relevant to AE(s) and Relevant Tests reported as None.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 01-OCT-2015 the patient was vaccinated with her third dose of GARDASIL 9 (lot # L027282, expiration date: 21-Sep-2017) (dose, route unspecified). The primary reporter stated that the patient started the series with GARDASIL "four or five years ago" (estimated as therapy started in 2010) for the first and second dose (Inappropriate schedule of drug administration) (Interchange of vaccine products). No adverse effects reported. Additional information has been requested.