chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse symptoms began about 2 to 3 hrs after the regular flu shot.  I became very tired and achy all over.  Now it has almost been one month and my muscles are still very stiff & achy.  This happened to me last year and the stiffness & achyness lasted for almost 6 months!  I don't think I'll ever get another flu shot again!
Patient received Tolapat office visit for Annual Exam. Denies any allergies. Patient called on 12-28-09 with c/o pain and swelling left upper arm that started 12/28/09 prior to that time her arms was just a little sore at injection site, when she got up 12-28-09 her arm was swollen and very painful, No tenderness at injection site but left arm was swollen with reddish purple areas on outer edges. Patient denies any elevated temp. Advised patient to see her primary care physician. She stated she didn't have PCP so lise of providers was given to patient. Stressed to patient importance of follow up with MD, she voiced understanding. Attempted to contact patient by phone. Phone numbers on chart not working.
Headache, body ache, abdominal/stomach cramps, chills, fever, sensitive skin
Patient had noted on consent forms that he had previously fainted after getting blood drawn. We spoke about this and he stated that he gets nervous with needles. After giving him his vaccine, he moved into our waiting area and within 2 minutes he fainted. His head was snapped back and his legs were out straight. I tapped him on the shoulder and shouted his name. He was unresponsive for approximately 30-45 seconds and in that time the ambulance was called. He came to and didn't have memory of what had happened, but stated that he was warm and began profusely sweating. The front store manager got him a bottle of water and when the paramedics arrived they took him on the stretcher to get vital laying down in the ambulance. I called the patient approximately 4 hours after the incident and he stated that the paramedics allowed him to leave on his own and he wasn't transported to the hospital. He noted a sore neck from when he head snapped back in the chair, but he was otherwise feeling fine.
In late January 2021, I noticed shortness of breath and irregular heart rate.  Also fatigue, and just general did not feel well.  I went to my PCP who referred me to a cardiologist for further work up.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.
MA gave patient DTAP-IPV and mixed it with sterile water instead of using the HIB to mix it with. So patient did not receive the HIB portion of the vaccine.
What apparatus to be pernio in my toes, followed by headache, then feeling like cool water is running though my legs, now tingling all over my body. This has lasted for four weeks now. Note, I am also nursing my 9 month old baby.
Patient was inadvertently administered the Pfizer vaccine before the age of 16.   She reported no adverse effects after vaccination.
Received 2 doses on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details reported were as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix on the same day, which led to overdose. The reporter did not consent to follow-up.
p/vax pt devel a chickenpox-like rash w/approx 8 to 10 lesions on head, face, mouth & cheeks;pt sought unspecified medical attention;
Rash ate site of injection as well as on arms, face, neck, back, and stomach. Rash is more prominent on cheeks and arms.
This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified patient of unknown age and gender. Information on concomitant medication, medical history, concurrent condition, drug allergies/reactions were unknown by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date were unknown by reporter) for immunisation. The reporter stated that an unspecified patient experienced pain and swelling at the injection site after receiving ZOSTAVAX and patient also experienced fever which lasted about 4 days. The outcome of injection site pain, pyrexia and injection site swelling were reported as recovered on an unspecified date. No product quality complaint (PQC) was involved. No additional information was provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2013, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. Late in 2014, the patient was treated by a healthcare provider for Shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was not recovered/not resolved. Causality assessment was related.
Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 01-MAR-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 01-MAR-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Mar-2022 at 9:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 01-MAR-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (Vaccines were initially placed in the refrigerator on 19-Jan-2022 and administered on 01-MAR-2022/Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. It was reported that, the vaccines were initially placed in the refrigerator on 19-Jan-2022 and were administered to the patient beyond the 30-days use by date. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up information received no new information.
Rolling Headache keeping me up throughout the night. Suicidal thoughts, Sore Arm, Cough, Difficulty Breathing, soreness at injection site, Brain fog.
Reported headache,light sensativity,pain, heart palpitations and fever 103F
Mom brought in 2 children for vaccines - baskets/containers were side by side - 5 yr old was kicking & fighting - grabbed the wrong basket & administered Flu & BOOSTRIX which were intended for 12 yr old child, who was also receiving vaccines.
Three days of severe headache, body aches, low grade fever, muscle aches, stomachache. Unable to function normally. Five days out, I woke with a very red, slightly swollen, itchy, tender upper left arm around the injection site and blossoming out from my shoulder to my elbow. That day I also had a milder version of the initial systemic symptoms which were mostly resolved by the evening. The localized reaction on my arm did not  resolve for about 4 days.
Initial information has been received from a nurse practitioner via field representative concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with an inappropriate stored second dose of GARDASIL for prophylaxis (dose, duration, frequency and lot number were not reported). No co-suspect medications were reported. No concomitant medications were reported. No adverse effect reported. The patient's outcome was unknown. No treatment information was reported. No laboratory studies were reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 71-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced dizziness, nausea and blurred vision. On an unknown date, the outcome of the dizziness, nausea and blurred vision were recovered/resolved. It was unknown if the reporter considered the dizziness, nausea and blurred vision to be related to SHINGRIX. Additional details were provided as follows: Greater than 4 days after receiving SHINGRIX, the patient experienced dizziness, nausea and blurred vision. In November 2018, all symptom were resolved. The reporter gave consent to follow up.
Excessive sleepiness and fussiness for three days, paleness for two days, and large (4cm) nodule in thigh for three WEEKS.
The baby had to be delivered at 35 3/7 weeks; Exposure during pregnancy; Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The infant had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring; This is a Spontaneous report from a contactable physician. This physician reported information for a mother and baby. This is baby report.   A neonate's  mother (mother was reported as 35-year-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN ), intramuscular on 02Feb2021  as a single dose for COVID-19 immunization. The patients mothers medical history and concomitant medications were not reported. The baby experienced fetal tachycardia noted 1 week after the 2nd dose of the vaccine in Feb2021 (also reported as 02Feb2021). The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring on. The patient was hospitalized for 5 days. The clinical outcome of Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring was unknown.  Information on lot number was requested.; Sender's Comments: Based on the available information a causal relationship between events "fetal tachycardia noted 1 week after the 2nd dose of the vaccine" and  "the baby had to be delivered at 35 3/7 weeks" and  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely 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.,Linked Report(s) : US-PFIZER INC-2021166872 mother/fetus
This spontaneous report as received from a physician refers to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis.  On an unknown date the patient experienced pain in extremity. The outcome of pain in extremity was unknown.
Redness at the injection site; Swelling at the injection site; Low grade fever; Extreme fatigue; Very sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, fever, fatigue and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, fatigue and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got his/her first shingles vaccine on Thursday (date unspecified).  The patient had redness and swelling at the injection site, a very sore arm, low grade fever and extreme fatigue the next day.  The patient was not looking forward to taking the second dose. Additional supportive information: The follow-up would not possible as no contact details were available.
Local reaction:  redness, slight edema, warmth to touch.  Fairly well-demarcated.
8/7/2018: evening - red and swollen top of left upper arm, approximately 4 inches in diameter, round red patch; ache and tender. 8/8/2018: 630 AM: woke up with migraine-like headache, light headed (would have fainted if I continued to get dressed); chills all day; nausea; sleepy. Slept on and off all day. I had to call off of my job today due to these side effects of vaccine. No pain relief for these side effects taken today. 8/9/2018: 630 AM: headache continued. Chills and nausea subsided. Upper left arm continues to be red, swollen and tender. Again I had to call off of my job due to the continuing headache. Work environment is in front of computer monitors for 8 hours, overhead fluorescent lighting, noisy, employees constant talking as employer is a call center type. No pain relief taken today. 8/9/2018 - 8/18/2018 (today): continued red, swollen red arm through this time period--tenderness subsided, but have large bruise and some redness today still (8/18/2018).
BREAKTHROUGH COVID INFECTION, MODERATE SYMPTOMS, CONSIDERING BUT NON-COMMITTAL TOWARD REGEN-COV WAS ILL SINCE OCTOBER 2021.  CAME IN ON 12/17  DUE TO PERSISTENT COUGH AND WHEEZE.  NEG COVID THEN.  GIVEN PREDNISONE AND ADVAIR.  PRESENTED AGAIN ON 12/21.21 THIS TIME POS FOR COVID..  HX COVID INFECTION 1/15/21.
Employee flu, vaccine give left upper arm. Hurt a little as fluid injected, but seemed normal injection, achy as usual following day. With 1-2 days it continued to be nagging, but was having spasms/tightness. After a couple of weeks spread to tightness in shoulder and neck, incorporated left shoulder blade. I first thought it would go away. Taking TYLENOL 2-3 x day since beginning, recently tried muscle relaxants; routine visit with chiropractor suggest PT and see PCP for continued spasms/tightening-> saw PCP starting PT scan and PCP said I should call Employee Health.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information about patients' medical histories, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of vaccination unknown, lot number and expiry date were not reported). On an unknown date, the patient experienced syncope. The outcome of the events was unknown at the time of the report. The relationship between the events and vaccination with GARDASIL 9 was not reported. This case is linked with MARRS # 1611USA007576 (same reporter). Additional information has been requested.
Wheezing - Albuterol Nebs, Depomedrol. Fever - Tylenol. Cough.
Patient came in with father for Pfizer booster; he received booster dose too early by 2 days from second dose on 9/26/21. Patient received booster on day 148 instead of day 150 or more. RPH spoke to parents on the phone after the incident, explained that patient received Pfizer booster dose 2 days earlier than standard schedule; RPH reassured parents that would not affect patient adversely and parents were being notified as standard communication. Patient's parents were notified of the event by RPH on duty and had no questions or concerns.
Patient received dose of IPV 11/28/18, 02/01/2019, 6/24/19 and 09/25/2019.  Received dose on 9/25/19 when not due.  Currently no documented adverse reactions.
Adverse event described as left arm and left weakness, random movements of left arm and left leg, onset 2-3 days following Moderna COVID-19 vaccine, per patient. I evaluated her 9/15/21, improved symptoms but still experiencing random movements of left arm and left leg. She reported she had been evaluated by another neurology office and was prescribed amantadine, which caused side effects. She was no longer taking it when seen 9/15/21. Ordered an MRI Brain and lab testing.
I started having symptoms on January 02, 2023 I experienced rash on my legs, stomach, and my back, not sure what my diagnosis is or will be I still have to visit my physician for more information on my symptoms
On December 1st I experienced mild malaise, slight headache and pulsing in both ears the day after booster shot which was received on November 30th.  From December 3rd to current date December 6th I have moderate consistent ringing in my left ear.   There is no relief from the tinnitus and continues day and night.  Some days are worse with not relief taking Tylenol or Advil.   I have contacted my nurse practitioner to report tinnitus but do not yet have an appointment to have it evaluated.
Swelling around both eyes. Lids and undereye edema.  No itch or pain.  Worse on 1/26/23 AM - slowly resolving.
Arm has been really sore; This is a spontaneous report from a contactable consumer or other non hcp.   A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Jul2021 08:00 (Batch/Lot Number: EW0158) as dose 2, single (age at vaccination 61-year-old) for covid-19 immunisation. Medical history included, she had bubbles, like pockets in her arm from an unknown. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number EW0165), via on an unspecified routed of administration, administered at left arm on 17Jun2021, administration site (age at vaccination 61-year-old) for covid-19 Immunization and patient did not have a reaction with the first dose. It was reported, Caller received her second dose of the Pfizer COVID vaccine on 08Jul2021. Caller states after receiving the second dose her arm has been really sore. Caller would like to know how long this tends to last. Caller would like to know what she should do if the pain gets really bad? Caller states she had no issues with the first dose, and everything was fine. Caller would like to know if because in the past she got pockets that had encapsulated from other vaccines if she should have gotten the Pfizer COVID vaccine both doses in the same arm? Caller states she received both doses in her left arm and they were given in the same spot. She had the second dose in the same arm. Caller was unsure if she should have it in the same arm. She had vaccines and it was like she had bubbles under her skin. It had encapsulated under the skin. This was a long time ago when you had booster shots. She can still feel the knots. The outcome for event was unknown.  Follow-up actions are needed. Further information has been requested.
Pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Nov-2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy).    No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported. Company comment: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who got pregnant and the non-serious and unexpected event of MATERNAL EXPOSURE BEFORE PREGNANCY was reported with no adverse event associated. The exposure was reported one year and a half after the third dose of mRNA-1273 vaccine, and no details of other doses were reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.