chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Chills; weaknes/loss of energy; bad cough that is lingering but it may be combined with allergies; Allergies; This is a spontaneous report from a contactable consumer (Patient herself). This 68-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number, Expiry date: not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had Covid in November and experienced GI symptoms. She received her first dose of the Pfizer BioNTech Covid 19 vaccine three weeks ago and experienced flu like symptoms such as chills, weakness, loss of energy. Her symptoms lasted for the weekend. She has a bad cough that is lingering but it may be combined with allergies. AE due to bad reaction after first vaccine. Reporter does not provide any details regarding second dose of the vaccine since she's already had covid. The outcome of the event unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
1 dose from 2 separate vials; Sore injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials), INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials), INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue). On 25-Jan-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials) had resolved. At the time of the report, INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
pt c/o scratching in genital area;neck;stomach & ears; has welts corners of mouth;MD said did not know if vax caused problems;benadryl & return to MD if not better; mom states hands/ears swollen;ears seemed sl puffy;pt appeared s/ distress;
This spontaneous report has been received from a nurse referring to a 21 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with a complete 3-doses series of RECOMBIVAX HB (strength, doses, routes, lot#, expiration dates and anatomical locations were not reported), as routine vaccination. The patient was seen in the medical office on 16-MAY-2017 and had "Hepatitis B titers drawn" (for an unspecified reason) which showed that her titers were low (hepatitis b surface antibody negative); no further clarifying information was provided. The outcome of hepatitis b surface antibody negative was unknown. The causal assessment between the event and the suspect therapy was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001140.
having the shakes; cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (having the shakes) and NASOPHARYNGITIS (cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (having the shakes) and NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (having the shakes) and NASOPHARYNGITIS (cold) outcome was unknown. Not Provided
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 11-APR-2013, the patient was vaccinated with an expired dose of GARDASIL (lot number reported as 0841AA, expiry date 08-APR-2013). Concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 15 months-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 09-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-1912USA001555:same reporter US-009507513-2006USA005616: US-009507513-2006USA003314: US-009507513-2006USA005620: US-009507513-2006USA005616:
Initially pain and chills. Post vaccine 11/2021 hip joint pain.  T bat evening followed by stiff neck,  neck day severe pain in injection site, neck, back, and areas where I had previous injury.  It almost feels like a complete immune response to these sights.  Still cannot move my next well.  Wake up with severe neck pain and burning.
Severe left arm pain / throb at injection site since March 31, 2021.  I have been wearing a pain patch to try and sleep at night.  Will not subside.
lightheaded/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded/Dizziness) 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 DIZZINESS (lightheaded/Dizziness). At the time of the report, DIZZINESS (lightheaded/Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was included.  No treatment drug details was provided.
6 hours after injection, the patient experienced a rash on arms, legs and chest. The injection site had swollen to the size of an apple, was red and hot to touch. She took anti-histamines and the rash is gone. Site is still sore.
3/24/99 pt exp fever redness swelling at inject site rt. Redness lasted 2days. Swelling 2.5 to 3.0 cm occurred at dtap inject., firm to touch.sx: om, rx: amoxil., cellulitis.
I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!; This spontaneous case was reported by a consumer and describes the occurrence of PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 086B21A and O37A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Jun-2021, the patient experienced PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!). At the time of the report, PRECANCEROUS CELLS PRESENT (I'm 62 ad for the first time in my life, I got an abnormal pap smear with PRE-cancerous cells on my cervix!) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2021, Smear cervix: abnormal (abnormal) Abnormal, PRE-CANCEROUS pap smear.         No Concomitant medication information was reported. No treatment medications were provided.
After the 2nd dose, about 8hr, I became very fatigues. I had a headache behind my left eye and a sensitivity to light that would not stop. My heart was pounding, and I had chills. About 3-4 days after, at the injection site, I had a red area that took over my arm. It was painful and itchy. My right arm was swollen for some time. My resting pulse is always at 100 something. At the beginning of august, I had pain directly right above my left eye. I was given migraine medication. The pain began to radiate along my jaw, check etc. after about 10 days of that, my neck felt enflamed, and my tongue had a funny feeling. At the urgent care, the pain in my face was diagnosed as trigeminal neuralgia. I then went to the ER trigeminal neuralgia. The ER dr said he was familiar with the neck being part of this diagnosis. He prescribed gabapentin and told me to continue Tylenol and Motrin. I told my PCP and she said I needed to see her. She put in a neurologist referral. I was put out of work for the 23 and 24. I saw my PCP on aug 24. She could tell I was in extreme pain. She prescribed the anti-convulsant and increased my gabapentin. This was helpful but I still have episodes. She also prescribed tramadol. She told me I could not return to work yet. I had a follow up on the 27, I told her all the episodes I had. I also told her I tried holding off on the medication, but the pain was at a 10. I am also not able to drive until further notice. On the 27, she told me I was out of work until 9/27. I have another follow up with her on 9/3. I have an MRI on 9/7 and a neurology appointment. Each day is something different for me. Also, certain foods can trigger the pain.
I had very little reaction to the first fax on Feb. 11 other than a slight fever and extreme fatigue through the 3rd day.  However, on the 9th day after the vax, I got "COVID Arm" which included upper arm swelling, red, itchy and achey at the vax site and another few days of extreme fatigue.  Today (18 days after vax) I am no longer fatigued, felt good when I woke up and I am finally getting some energy back.  The redness, swelling and itching is subsiding but is not gone totally and there is only a slight discomfort in my arm.  Moderna Vaccination #2 is on March 11 and it will be in my other arm.  Only took Aleve twice for pain.
Information has been received from a pharmacist concerning a 51 year old female patient. Pertinent medical history or drug reactions/allergies were unknown. On 21-JUN-2015, the patient was vaccinated with an expired dose of MMR II (Lot number: # J006953 with expiration date: 07-JUN-2015, dose, route were unspecified). No adverse effects were reported. Additional information has been requested.
Woke up at 4:00 AM nauseous and with extreme headache. Felt dehydrated. Drank some water--- then began vomiting about once every 20 minutes to an hour. Could not keep even a sip of water down. Felt febrile and was shivering -- thermometer read 99 degree temp. Injection site was warm. Arm was sore (same as with 1st injection in the series). But this time, entire body ached. Could not get comfortable. Every muscle/joint ached. Could barely sleep as head hurt so badly, it felt like my brain was swelling beyond the container of my skull! Took 325g TYLENOL but vomited it up. Waited until morning to see if symptoms were getting worse. By 8:00 AM, still could NOT eat. Still could not drink. Had a little diarrhea. Remained in and out of an exhausted haze for hours and hours. Shivering, feeling generally miserable. By 3:00 PM on the 30th, could finally keep down a TYLENOL. By 5:00 PM finally began to feel only slightly better. By 10:00 PM, I had 1/3 chicken broth and was able to hold it down. Slightly less severe headache remained. By 11:30 fell asleep. Next morning, the pain was finally subsiding, headache less severe. Could actually eat a scrambled egg for breakfast. Slowly began to feel better. By Monday, was 95% back to "normal."
7 hours after shots developed vomiting associated with shaking (not felt to be seizure), local swelling of entire right thigh 2 1/4-5 inch discrepancy in circumference, 5x7 inch area erythema and induration.
Mother stated patient was vomiting and twitching approximately 10 hours later after receiving vaccine.
Had a headache, tired, stomach issues, diarrhea, & didn't feel well the day after shot or the 2nd day following shot. Arm was sore.
rash on lt arm (lower 1/2 of arm), inside of knees (both) & near ankles (inside portion); felt some nausea last PM also but no vomiting; no fever or nausea @ this time;
persisent, very mild soreness / very minor soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient got the second Shingrix vaccination about a month ago and was still feeling some very minor soreness after 4 weeks. The patient was just wondering if there was any known side effect from the Singrix vaccination that might cause persistent, very mild soreness for an extended period of time after the second vaccination. The patient wanted to know how long soreness may persist after Shingrix vaccination.
Approx 12 hrs post vaccination patient started with symptoms of sharp pain in arms travelling up into her neck. Also shooting, stabbing pains in legs, Left ankle, and back. Pain described as debilitating, lasting approx 12 hrs. Also C/O chills, fever, body aches during same time frame.   She also had a rash on her arm, not at vaccination site, that was itchy and very painful to touch(shingles-like rash) which resolved after 1 day. No further symptoms.
Started having normal side effects, fever. Then started having sharp pains in arms and headaches, brain fogs. Visited neurologist has not received results yet.
Dark red, warm, swollen, painful area ~6 x 8cm anterior Rt. deltoid.  Mother reported giving TYLENOL & applying cold pack.  Client said it "feels better now."
She had Covid in Aug 2021 even though she was vaccinated; Se had Covid in Aug 2021 even though she was vaccinated; covid related pneumonia; This is a non-interventional study report from a contactable consumer (patient) based on the information received by Pfizer from regulatory authority (Mfr. Control No.: 21K-163-4097505-00).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), intramuscularly on 01Mar2021 (at the age of 76 years) as dose 2, single for COVID-19 vaccination; and adalimumab (HUMIRA), subcutaneously from an unspecified date to Aug2021, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) intramuscularly on 01Feb2021 (at the age of 76 years) as dose 1, single for COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient experienced COVID in Aug2021 even though she was vaccinated. Patient had covid related pneumonia on an unknown date in Aug2021 and had to come off of Humira since Aug2021. She was initially in hospital for six days. It was reported that, patient took a break from Humira for a little while until covid test was negative. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid on Aug2021. The action taken in response to the event for adalimumab was temporarily withdrawn on an unspecified date in Aug2021. The outcome of the events was unknown. Causality as per reporter with bnt162b2 was reported as possible for event COVID-19 and for COVID-19 pneumonia was not reported. The reporter's causality for the event of COVID with Humira, was a reasonable possibility and reporter's causality for the event of serious COVID related pneumonia was not provided. Causality as per Mfr. (Humira) was reported as no reasonable possibility for both the events.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and covid-19 pneumonia and the suspect drug BNT162B2.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 09-APR-2018, at the age of 15 years, the patient was vaccinated with second dose of Oka-Merck PROQUAD for prophylaxis (drug administered to patient of inappropriate age). Patient received first dose on an unspecified date. No adverse effect was reported. No product quality complaint was involved.
Large red itchy warm area around injection site that continued to grow for four days Applied Benydrl cream to stop the itching
Runny nose, cough, shortness of breath, wheezing, coughing, chills, tinnitus.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant medications was provided by the reporter.  Patient received half dose. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022.  No treatment medications was provided by the reporter.
Headache, Arthralgia, Fever, UrticariaPruritus, chills Narrative: Pt reported fever, chills, skin-crawling feeling, arthralgia, & headache day after vaccine #2 dose given. Pt did not treat. Symptoms resolved.
Mother called 3/20/2006 same lesions as sibling who was seen in office on 3/3/06 approx 56 poxes. Resolved in 2 days.
Prior to flu vaccine administration, pt will take 80mg of DepoMedrol. This year she did not. Pt started to get flushed and heart palpitations approx. 1 hr after administration of flu vaccine. Pt was given 80mg of DepoMedrol, 25mg Bendaryl, and Pepcid. At 0900 she was starting to feel better, heart palpitation resolved, flushed face improving. At 1130 pt had completed resolved symptoms of reaction.
There were no adverse events but the vaccine was administered to the patient after the mother gave a DOB that made the patient 12 years of age. When they came for the second dose it was discovered that the patient was only 11 years old