chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis came back; Positive for lupus; Hip/ankle/knee ache; Back ache; Right foot and couple of toes ache; COVID injection cause her arm to swell up; Aches and Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4380909-00 (AbbVie).  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160679), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis came back"; ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (non-serious), outcome "unknown", described as "Positive for lupus"; ARTHRALGIA (non-serious), outcome "recovering", described as "Hip/ankle/knee ache"; BACK PAIN (non-serious), outcome "recovering", described as "Back ache"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Right foot and couple of toes ache"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "COVID injection cause her arm to swell up"; PAIN (non-serious), outcome "recovering", described as "Aches and Pain". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: Positive for lupus. The action taken for adalimumab was unknown.  The reporter assessed causality between events "rheumatoid arthritis came back", "positive for lupus", "hip/ankle/knee ache", "back ache", "right foot and couple of toes ache", "covid injection cause her arm to swell up" and "aches and pain" and BNT162b2 as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, a contributory role of the suspect product BNT162b2 to the reported events cannot be excluded. Vaccination date and event onset dates  were not provided. Case will be reassessed upon receipt of additional information. 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.
No adverse symptoms reported; who was 9 months old, received a dose of MMR II and VARIVAX; Information has been received from a physician referring to a 9 months old patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant Medication included sterile diluent (STERILE DILUENT).     On 26-DEC-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA(strength, dose detail and route were not reported) (lot # S013719, expiration date 05-MAY-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and route were not reported) (lot # S012036, expiration date 17-APR-2021) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms were reported.
33 hours post vaccination: experienced heartburn, discomfort followed by urticaria on my neck, trunk, armpit, and back.  Took diphenhydramine.  Woke up with no itching by some swelling of left eyelid.  At 1500 1/7/21, some outbreak of urticaria on my back, underarm, neck, trunk area, and groin area.  Took lower dose of diphenhydramine.
Patient requested a COVID-19 booster and a flu shot. She received her immunizations and then presented her COVID card. The card stated she had already received a bivalent booster on 10/7/22. The patient was under the impression she needed to receive 2 bivalent boosters. We explained that she should not have this vaccine today and she is not to receive any more COVID vaccines at this time. She stated that she was confused but felt fine after receiving the vaccine. Patient reported no issues or side effects with previous COVID vaccines. After 15 minutes of observation, she did not report any issues.
Administered ADULT PFIZER MONOVALENT GRAY instead of ADULT PFIZER BIVALENT BOOSTER  Could not get a hold of the patient after 2 attempts
patient received  comirnaty ( new pfizer covid vaccine right arm, and fluzone HD left arm) around 942-948 am on saturday 10-7-23.  sometime around 10 -1010 am pt was on ground ( fainting or dizziness). EMS was called immediately  and arrived at 1017 am.  Patient was alert and talking almost immediately after fall, but kinda just stayed put lying on back on ground until ems arrived. vitals were good. pt declined getting blood sugar tested by ems and upon ems arrival she just stood up and said she was fine and declined any further treatment. I actually called the patient on 10-8-23 to check in on her and she said she was fine, other than some minor cuts and bruises and said she thinks she was just overly worked up due to getting two vaccines for the first time ( since she usually only gets one at a time) but today she wanted to get two vaccines and during vaccination she mentioned no previous concerns and has received multiple vaccines over course of our history with her and throughout her life. with no history of any adverse events. she did mention after she was alert after falling (fainting-dizziness) that when she was " younger" this would happen to her sometimes but didnt say what caused it.  I did speak with patient and I told her this was to be reported and she asked if I would just fill out the necessary information and asked she would rather NOT have her demographic specifics and name listed. which is why I didnt fill out those fields.
shingles and other zoster-related conditions; shingles and other zoster-related conditions; death; Information has been received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 29-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number, anatomical site of vaccination and route was not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles and other zoster-related conditions. It was also reported that the patient received medical attention and treatment for the events (unspecified). On 13-JUN-2020, the patient passed away. It was unknown whether an autopsy was performed. The cause of death was not reported.   At the reporting time, the outcome of the shingles and ill-defined disorder was not reported. The reporter considered the shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between the patient's death and zoster vaccine live (ZOSTAVAX) was not reported.
Patient with a past medical history of CVA maintained on clopidogrel, neurogenic bladder followed by urology and has a suprapubic catheter who was hospitalized from 3/21/2022 to 3/22/2022 for urinary tract infection. Patient was initially seen in emergency room on 3/17 and had urinalysis performed but would not wait for the results so no antibiotics were prescribed. While hospitalized he was given ceftriaxone and he was discharged on cefdinir. ED visits to hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax 24MAR97 & 12APR87 exp ankle edema & arthritis-like pain in the lower extremities;pt recovered;
cellulitis; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; It does still hurt a little bit; she had noticed a reaction that evening; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206, expiry date not reported), via an unspecified route of administration, administered in the left arm on 10Mar2021 as single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergy to bees and spider. There were no concomitant medications. The patient previously took tetanus vaccine in 1974 and experienced pharyngeal swelling. The patient said that she wanted to report that she has had a reaction to the COVID vaccine. She received the COVID vaccine on 10Mar2021, that morning, and she had noticed a reaction that evening around 8:00 PM. It started out about the size of a quarter. She took Benadryl and then she went to bed. When she woke up the next morning, her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen. It is still a little bit red, but not near like it was. It does still hurt a little bit. She got her daughter to take her to the emergency room and from there she was placed on a medication and she has been on that medication ever since. She has no intention of taking the second COVID vaccine. Clinical outcome of cellulitis and vaccination site reaction was unknown while for the other events was recovering.
Sore arm immediately, that night tired, muscle aches. Overnight, fever, chills. Next day felt like I got hit by a bus. Headache the whole time. Ibuprofen. Next night, fever 101 degrees.  At 48 hours after vaccine, felt mostly normal.
Right arm redness, warm to touch, sore ness, itching, swollen x 2 days
Chills; Sneezing; Headache; Cold (disease); overload of phlegm in throat; eyes infected; COVID-like symptoms; The patient had dry cough that lasted for 2 weeks; Joint pain; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included shingles and asthma. Previously administered products included Prevnar. Concurrent medical conditions included type ii diabetes mellitus.   On 13-OCT-2023, the patient received the 1st dose of Arexvy (left deltoid). In OCT-2023, 1 week after receiving Arexvy, the patient experienced covid-19 (Verbatim: COVID-like symptoms), dry cough (Verbatim: The patient had dry cough that lasted for 2 weeks), chills (Verbatim: Chills), sneezing (Verbatim: Sneezing), headache (Verbatim: Headache), cold (Verbatim: Cold (disease)), phlegm (Verbatim: overload of phlegm in throat) and eye infection (Verbatim: eyes infected). On an unknown date, the patient experienced joint pain (Verbatim: Joint pain) and nausea (Verbatim: Nausea). The outcome of the covid-19, chills, sneezing, headache, cold, phlegm and eye infection were resolved and the outcome of the dry cough was resolved (duration 2 weeks) and the outcome of the joint pain and nausea were resolved (duration 3 hrs).   It was unknown if the reporter considered the covid-19, dry cough, chills, sneezing, headache, cold, phlegm, eye infection, joint pain and nausea to be related to Arexvy.     It was unknown if the company considered the covid-19, dry cough, chills, sneezing, headache, cold, phlegm, eye infection, joint pain and nausea to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-NOV-2023 The reporter was the patient. The reporter stated that week after gsk shot, the patient had worst cold-felt like every toxin came out-never had a temp but had lots of dry coughing through out. Many Covid-like symptoms:overload of phlegm in throat, headache, dry cough( almost throughout) eyes infected, sneezing, chills,went through 4 boxes of tissues at end of second week, felt better. The patient did all the things, she usually do when sick. The patient stated that if this was from shot, she was truly grateful but it was hell going through it. This agent made an outbound call to gather further information. The GSK shot was clarified as AREXVY.  After receiving the vaccine, the patient experienced nausea and joint pain which went away after three hours. After 1 week, the patient began experiencing COVID-like symptoms. The patient stated she tested for COVID twice but each time was the result was negative. The patient never had a temperature and never experienced such a cold with any other vaccine. The patient had dry cough that lasted for 2 weeks. The patient inhaled steam to alleviate symptoms. The patient felt fabulous now. The reporter consented to follow up. Depending on the weather she could have a tiny bit of Asthma. The term "eyes infected" was not clarified. The patient referred to her symptoms as a Cold (disease), as well as COVID-like symptoms.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323310, 2018SA323312 and 2018SA323314 (same reporter). This case involves a 18-year-old female patient who was vaccinated with a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (Batch number: UT6315PA, expiration date: 30-Jun-2019, route: intramuscular and site of administration was left deltoid) on 21-NOV-2018 date. The patients medical history and concomitant medications were not reported. It is an actual medication case error due to vaccine underdose. It was reported that they accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVALENT instead of the 0.50mL dose.  The patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Lightheaded, claustrophobic wheelchaired to medical tent and passed out states "this happens with needles". Pt rested on cot and voiced she felt better. Pt refused EMS AMA upon EMS arrival.
This spontaneous report was received from a other health professional refers to a 15 years old male patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, who on 10-JUL-2012 at 11:30, was vaccinated subcutaneously in her left deltoid with the first dose of VARIVAX (lot number 1274AA) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUL-2012 the patient experienced erythema multiforme with fever 102. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for erythema multiforme and fever 102 was unknown for VARIVAX (Merck). Additional information has been requested.
Pt was okay at the time of the injection. The following day he experienced swelling at injection site and a systematic inflammatory response. Pt is a medical doctor so did not seek medical attention from his PCP and took care of treatment on his own. He is now following up with his doctor and an immunologist to pursue further treatment and investigation.
Starting 24 hours after receiving vaccines, patient developed a fever and then slept 18 hours, waking up only to vomit twice during that time. Fever resolved afterwards.
Pt. c/o heaviness of tongue after receiving the vaccine.  Pt. seen and assessed by EMS.  All vitals are within normal limits.  No swelling noted.  Pt. voiced that the sensation was no longer felt and was cleared to go home by EMS.
A large red swollen area at the injection site 2.5 inches long, 2 inches wide hot to the touch.
Pt was given 0.3mL of 12+ pfizer instead of 0.2mL of 5-11 pediatric dose of pfizer for 2nd dose in the series.
Patient received only DTaP-IPV vial of Pentacel vaccine. Patient did not receive Hib powder vial for reconstitution.
Onset of erythema, minor pain and minor induration at site within 12-24 hrs. Area of approximately 19 x 13 cm mild erythema and mild warmth with approximately 3.5 cm area mild induration measured 48 hr after injection. Pt states sxs already improving at this point.
Facial tic (eye blinking and facial twitch) reported to have started 1 wk after receiving H1N1 vaccine.
Vaccines give 9/26/08 and pt presented with febrile seizure 10/5/08, lasting over 15 minutes, requiring Ativan, pt required intubation and overnight PICU stay for hypercarbia, discharged after 48 hours.
Hospitalized with abdominal pain, increasing shortness of breath, fatigue, and nausea and vomiting
Pt recvd Hep B vax in 1987 or 1988; The pt devel vasculitis and/or temporal arteritis; No further details were reported;
I've had the vaccine, too. But I have had the shingles since; I've had the vaccine, too. But I have had the shingles since. A very mild case; Pain; Numbness / Still having numbness; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and numbness. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles and numbness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and numbness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received shingles vaccine and experienced shingles, pain, numbness and a mild case with no blisters. The reporter mentioned that, patient still had numbness. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt noticed redness and swelling in left deltoid where Pneumovax had been administered. On 11/13, erythema extended from the mid humerus down to the wrist and she was admitted to the hospital for observation. It was tender, warm to palpation, and there was moderate swelling. Treated with IV levo. 12-15/05  Review of 2-page medical records final dx cellulitis L arm (site of pneumonia vax).
This spontaneous report was received from a female consumer referring to herself currently 85 year old. The patient's concurrent conditions included, Bell palsy and hypersensitivity reaction to sulfa medications. There were no concomitant medications. On 05-NOV-2007, the patient was vaccinated with 1 dose of ZOSTAVAX (dosage, frequency, anatomical location, route of administration, lot# and expiration date were not reported) for prevent shingles. The patient reported that she developed shingles in April 2013, after receiving ZOSTAVAX. She further stated that she was admitted to the hospital in April 2014 to have her left knee replaced. The patient stated that currently she was dealing with a burning and itching feeling over her face, additionally, she stated that she had been diagnosed with post herpetic neuralgia (PHN). It was reported that on unspecified date she sought medical attention at the physician's office, also that a routine blood work was performed and no results were provided. The patient also mentioned that she had "issues" with oxycodone (unspecified). She stated that the medication gave her hallucinations. The patient stated that her nurse commented her that while on medication; she stated "there were dragons in her bed". The outcome of herpes zoster and post herpetic neuralgia was reported as not recovered. The outcome of knee arthroplasty was unknown. The relatedness between herpes zoster, hallucination, knee arthroplasty and post herpetic neuralgia with ZOSTAVAX was not reported. Upon internal review, the event of knee arthroplasty was considered to be a medically significant event.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 72 hours, with the lowest recorded temperature of 33 degree Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received pneumococcal vaccine 10/14/2003.  Following day developed fever, chills, severe pain from elbow to shoulder on affected arm.  Area extremely tender to touch.
Left arm redness, pain and swelling/hot to touch - next day reaction. Treat with KEFLEX.
Vaccine given 10-6-07 that evening left arm swollen, hot, red. Questionable fever got worse in Sunday decreased redness on Monday.
Patient complained of Headache, there was no vomiting. Had a loss of conciousness for about 3 hours. Pt is stable now in the hospital.
Very itchy and red at site of shot. Next day itching got less. Area was kind of hard, lifted, and red.
Patient stated she had a history of fainting with blood draws. Patient stated she did eat before vaccination. Nurse on hand as well as another person to assist if needed. Patient was administered vaccination by medic within 3 min started feeling nauseated and sweating she lost consiouness. Medic and public health nurse able to lie on floor patient safe and did not hit her head. Ambulance staff paremedic on site. B/p taken 90/58, O2 98% 66 Pulse. Cool cloth to head and ice packs to neck. Within a minute Patient regained cauntiousness. Juice given. Patient was able to eat a cookie. Stated she was feeling better. Assisted tranfer to wheelchair to monitoring station for additional 30 min. Patient declined to be taken to local hospital via medics. B/p reassed at 0112 10/98 100% o2 68 pulse. Patient able to talk and drink water without any problems. Patient was present with husband. Patient monitored a aditional 30 min. before leaving. Patient gait steady and no slurring of speech. Patient was advised if any problems arise to seek 911. Patient stated she would not be driving home her Husband would.
Fever, highest 101.3, chills, fatigue, body aches, headache. Treated with Tylenol and Ibuprofen