chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hand tingling; Face tingling on the right side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), CINITAPRIDE and PIOGLITAZONE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side). At the time of the report, VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Had mild eye burning; muscle pain; Arm was more sore than the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EP7533, Expiration Date: 30Dec2021) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing; "anaphylactic shock" (unspecified if ongoing), notes: 40 years ago used to go into anaphylactic shock a lot, was treated. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: Ether EN6208 or FN6208, providing from patient record card, Received in left arm), administration date: 16Mar2021, for Covid-19 Immunization, reaction(s): "Eyes started burning a lot", "Sore arm"; Shingles, administration date: 03Sep2021, for Immunization; Flu, for Immunization, reaction(s): "Felt pretty lousy heading into work". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Arm was more sore than the first dose"; EYE IRRITATION (non-serious) with onset 06Apr2021, outcome "recovered", described as "Had mild eye burning"; MYALGIA (non-serious) with onset 06Apr2021, outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Had mild reactions with the first two doses, one was discomfort in the arm. He reported his reactions with first two doses. Didn't call Pfizer. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
received in early 2021, Covid hit, clinic closed down; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received a 1st dose of Shingrix vaccine. Then Covid hit and the clinic where he/she was getting the 2nd closed down. It had been about 1 and half years.  The patient wanted to know did he/she started over. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Post-second Moderna vaccine: initial heaviness of arm, for first 12 hours, a little soreness, some muscle fatigue - felt like I couldn't stand up straight = too much effort. Went to bed, with 2 @400 mg. Tylenol boosted during the night with Tramadol 50 mg.   Was able to drive & swim in the morning (21 hours) post. 24 hours post: extreme fatigue (kept falling asleep), then felt like I'd been run over by a rototiller. Aches in joints, body, and skin.  2 @ 400 mg Tylenol alleviated symptoms enough to sleep for 2 hours. Arose at 3:30 pm feeling better. Not great, but better ! Better enough to feed animals and prepare dinner for myself.
Tenderness, redness right upper arm developed about 18 hours after injection. Area does not appear swollen. Patchy pink areas noted above injection site but seem superficial and not uniform in size or shape.
redness , tender, itchiness, increased on the Jan  21, 2021 accompained by sorethroat, chills, body aches and  left side axillary lymphnode .
Possible "covid arm" , reports red area looking like hives on the arm of injection, delayed " a few days" after shot.
Vaccines were kept frozen until they are ready for administration; Administered Moderna vaccines beyound the use date/expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyound the use date/expired.) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 24-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain upon injection; injection site of the pneumovax was reported as being given in the Left Deltoid.  However, upon inspection, it appears the injection was given sub-acromially.  No redness or swelling at the area, but it is warm to the touch.  The patient is completely unable to abduct her arm.  Pain is extreme.  She was given Celebrex and Tylenol without any relief.  Ice pack was also given.  I am a physician and have examined her myself.  I have never seen this type of reaction before.
Extreme pain in Left arm and around waist and unable to ambulate without assist several days later.
Pt called in c/o sore arm and swelling and pain with difficulty moving arm. Advised to take Nsaid and increased fluids, left arm swollen shoulder to elbow, redness, no fever. 8/8/05 advised to go to urgent care, didn't. No to taking antiinflammatory or Tylenol, swelling decreased still having difficulty moving arm, advised to seek care.
Soreness at the injection site, Headache. Treatment: Tylenol, Outcome: No improvement.
Had a severe reaction; Bones felt like electricity was going through them; Sick; Injection site was initially black and blue; Chills; Nauseas; A fever of 101; Tired; Didn't feel great for a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel great for a day), VACCINATION COMPLICATION (Had a severe reaction), BONE PAIN (Bones felt like electricity was going through them), VACCINATION COMPLICATION (Sick) and VACCINATION SITE DISCOLOURATION (Injection site was initially black and blue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MALAISE (Didn't feel great for a day). On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (Had a severe reaction), BONE PAIN (Bones felt like electricity was going through them), VACCINATION COMPLICATION (Sick), VACCINATION SITE DISCOLOURATION (Injection site was initially black and blue), CHILLS (Chills), NAUSEA (Nauseas), PYREXIA (A fever of 101) and FATIGUE (Tired). At the time of the report, MALAISE (Didn't feel great for a day), VACCINATION COMPLICATION (Had a severe reaction), BONE PAIN (Bones felt like electricity was going through them), VACCINATION COMPLICATION (Sick), VACCINATION SITE DISCOLOURATION (Injection site was initially black and blue), CHILLS (Chills), NAUSEA (Nauseas), PYREXIA (A fever of 101) and FATIGUE (Tired) outcome was unknown. Not Provided          No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Hives, bright red color all over body face and extremities, facial swelling, Chest and throat tightness, difficulty taking deep breath,  Treated with Epi pen, Benadryl 50 mgs x3,  Pepcid.  Required Benadryl for wo additional days
Severe swelling of left and right hands, fingers, forearms and eyes. Upper lip also swelled. Swelling continued for 4-5 days straight, but subsided after prednisone administered. Severe itching and redness continues throughout my body at random spots and at random times throughout the day. Going on week 3: severe itching and redness continues.
Described throat tightness, itching of face/skin. BP 160/110 with medium BP cuff. HR 85 SPO2 97%. Describes feeling shaky. Reports history of anaphylactic reaction to allergy shot for bee stings. Reports history of feeling "panicky". After 30 minutes at rest, reports throat tightness improved. Reports never had difficulty breathing, just a tightness in the throat. Reports increase in skin itching, but has a history of similar reaction when exposed to mold in buildings.
Pt developed severe respiratory distress that led to respiratory failure. Subsequently, despite mechanical ventilation, develped hypotension, bradycardia.
Contracted Pneumonia and was in ICU for a week; Contracted Pneumonia and was in ICU for a week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for pneumonia. The patient's medical history and concomitant medications were not reported. The patient experienced contracted pneumonia and was in ICU for a week (hospitalization) on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Pt came by clinic 5/17/14 to report event she received her 1st Hep A vaccine, developed a mild pruritic rash on chest and low face. Today some slight spread of rash upper face. No known unusual exposures. Denied SOB/wheezing. Instructed take ZYRTEC, monitor sym - ER if worsens. 5/20/14 Talked to pt today, had no further rxn, rash subsiding.
Had shot on 4/10 ,4/15 woke up with rash/hives/itching all over upper body and head. 4/16 spread to my legs and feet. also have upset stomach since 4/13 with vomiting only on that day.  Johnson and Johnson vaccine
Patient had facial twitch and his tongue felt like it had a film on it around 3/17/2021. Patient had right sided facial paralysis starting 3/21/2021. Patient went to the ER that day and was diagnosed with Bells Palsy. Was Given IV steroids that day in the ER and was put on oral Valtrex and Prednisone. Patient was told that symptoms were caught early. 3/24/2021 patient reports that symptoms are starting to resolve and he is starting to get more feeling around his mouth.
Pt called this morning at 10:46am to notify us of his adverse reaction to the vaccine.  Received vaccine 11/8/19 and on 11/9/19-11/10/19 he woke up with an odd headache, extremely blurry vision, and nausea.  Stated he was walking to his mailbox and his knees buckled as he got dizzy and fell into the snow (no reported injuries).  He said he continued falling after he got up and had to crawl into his house.  He has notified his MD and waiting to hear back.  I asked if he had checked his BP, he stated it was around 115/48 when he had checked that day.  I asked if he could have taken his BP medications twice on accident.  He said he is unsure and it was a possibility but he feels it was unlikely due to the BP meds and more of a reaction to the vaccination.  He has been advised to reach out to his MD and continue to monitor his BP.  Asked pt if he has had flu vaccinations in the past and he said "yearly with no issues."
tingling from knee to foot mainly in the foot; left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later; muscle spasms that occur around knee near the side and back of the knee; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from knee to foot mainly in the foot), HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later) and MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMITRIPTYLINE for an unknown indication.    On 17-May-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later). 18-May-2021, the patient experienced MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee). On 18-May-2021 at 9:00 PM, the patient experienced PARAESTHESIA (tingling from knee to foot mainly in the foot). At the time of the report, PARAESTHESIA (tingling from knee to foot mainly in the foot), HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later) and MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee) 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 medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 contains added event of muscle spasm and event outcome updated to not recovered.
This case was reported by a consumer via call center representative and described the occurrence of induration in a 37-year-old female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced induration, mass, skin warm and redness of legs. On an unknown date, the outcome of the induration, mass, skin warm and redness of legs were recovered/resolved. It was unknown if the reporter considered the induration, mass, skin warm and redness of legs to be related to DTaP vaccine. Additional details were provided as follows: The patient received 3 doses of the Tdap vaccine starting when she was 3 months old. The patient developed a hard knot in her left leg the size of a pea or a walnut. The area was also red and warm to touch and resolved after a week. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). The reporter had 3 kids and the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it. For tolerance to further doses, refer cases US2018GSK232635 (2rd dose) and US2018GSK232634 (3th dose).
Loss of hearing in Right ear with constant ringing.; Loss of hearing in Right ear with constant ringing.; Dizzinessd and lightheadedness; elevated BP.; This is a spontaneous report from a contactable healthcare professional reporting for herself.  A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number FF2588) on 04Sep2021 at 14:00, at the age of 60 years, as the first single dose, in left arm, for COVID-19 immunisation. Medical history included mitral valve prolapse. The patient did not have COVID prior vaccination. Concomitant medications were none (no other vaccines were administered in 4 weeks and no other medications were administered in 2 weeks). On 04Sep2021 at 14:30 the patient experienced loss of hearing in right ear with constant ringing, dizziness and lightheadedness with elevated BP. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment (flushed ear and told to go to ENT/take Advil). COVID was not tested post vaccination. The events had not yet resolved.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Deafness unilateral  cannot be totally excluded.The impact of this report 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.
Sore arm; Fever blisters on and above my lip; Soreness at injection site a little itchy; Soreness at injection site a little itchy; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 22Feb2021 17:15 (Batch/Lot Number: EW6200) as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy from an unknown date. The patient's concomitant medications were reported as none. No COVID prior to vaccination. Not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 08:00, the patient experienced soreness at injection site a little itchy. On 03Mar2021, the patient had sore arm and fever blisters on and above my lip. No treatment was received for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Patient received 3 Pfizer COVID vaccines on 1/19/21 (lot # EL3248), 2/9/21 (lot # EL9264), and 10/26/21 (lot # FH8028).  On 1/22/22, patient admitted  with septic shock (likely from complicated UTI with indwelling  foley catheter), AKI on CDK III-IV, MRSA colonization with history of septic knee, and incidental COVID19 infection. As of today (1/25/22), patient is still admitted and COVID19 infection asymptomatic (not hypoxic).
My eyes swelled shut, this was the booster. When I got the first JOHNSON and JOHNSHON in March of 2021 I was extremely nervous because I have the lupus anticoagulant and a week later it was taken off the shelves for blood clots.
Information has been received from a physician concerning an adult female patient who about two weeks ago on approximately Sept 06 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). In Sept 2004, the patient developed injection site reactions that included swelling and redness. Subsequently, the symptoms resolved within a week. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned another patient (WAES0409USA01690) who had developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The reporter listed several patients not quantified experienced multiple adverse reactions stated in the prescribing information after receiving SHINGRIX. The reporter stated pain, redness and swelling at the injection site and also reported flu-like symptoms, weakness and shivering. The reporter stated she did not have the specific data but spoke from experienced with patients at the time of the call. No additional information provided.
pt recv vax 25JUL95 & bumps broke out on stomach, chest some on legs & in hair Wed Am;DPH cream applied to rash;no fever; liquid DPH used & it helped more;31JUL95 drying papular rash scattered; itching