chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the injection site.; sore arm; arm felt feverish; This is a spontaneous report from a Pfizer sponsored program via a consumer reported for a patient (reporter's daughter in law). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in 2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location an unspecified date in 2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and experienced flu symptoms for a week after the first vaccine, her arm felt feverish and sore arm on the injection arm. She felt like she had the flu for 5-7 days. Her doses were either in Apr2021 and May2021 or May2021 and Jun2021. It was the end of Apr2021 or the middle of May2021 and the second one was probably in Jun2021. On an unspecified date in 2021, the patient experienced pain at the injection site, sore arm and her arm felt feverish. She didn't want to report it because she felt like it was normal. The reporter and her daughter in law had the same side effects. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119253 same reporter/SD/AE,different patient
Received Unauthorized Vaccine for his age. He has soreness on arm , arm pits and pain on lateral side of chest for 1 day
Pt had received a 4th dose of DTP when he was 6 years old. His mother related that he had an abscess and fever from it and was hospitalized for 2 days following the injection. Since the client needed a Tdap, the regional nurse was consulted and she felt the benefits of the injection outweighed the possibility of a local reaction and reasoned it was ok to give the shot. The Tdap was given in the morning of 07-28-09. At 5 pm the client was called and reported his arm was sore but no redness or swelling. On 07-29-2009, the client reported his arm was swollen, red and sore and had an egg size knot at the injection site. He was advised to apply ice and take a ibuprofen or TYLENOL. On 07-30-09, he had a swollen lymph node in rt axilla but he said although his arm was still swollen, it was better. When the client awoke on 07-31-09, he noticed a large soft and puffy area on his chest, directly under his Rt. Axilla-------it was not tender but his mother wanted the PA to see it--------he ordered four days of Prednisone and told her he was trying to keep an abscess from forming and that the client should not take any more TETANUS. In the afternoon of this day, the client had no swelling or redness in his arm where the injection was given and had lifted weights and done painting during the day. On 08-03-09, the client was called and the mother reported he had a good weekend and was dong just fine now.
Were real sick for a while; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for her friends. The age at vaccination was not reported. The patients received Shingrix and sick for a while. This case linked with US2019AMR200928 and US2019200243, reported by same reporter.
Information has been received from a registered pharmacist and a registered nurse concerning a patient who on Oct 11, 2002, was vaccinated by a registered nurse with a dose of pneumococcal vaccine 23 polyvalent (lot#640981/1050L), intramuscularly in the deltoid. The registered pharmacist reported that he heard from a physician's office that three members of the office staff received pneumococcal vaccine 23 polyvalent and experienced swelling from the site of the injection down to almost the elbows. The registered nurse reported that three employees were vaccinated with pneumococcal vaccine 23 polyvalent on Oct 11, 2002. All three patients experienced soreness in a few hours. The swelling appeared that night. The area was warm and inflamed. This patient also had nausea the next day. Two of the patients were treated with ice. The reactions seemed to resolve in 48 hours. Unspecified medical attention was sought. Related reports: WAES0210USA01548 and WAES0210USA02050. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released. Additional information has been requested.
1540 patient received vaccination, 1543 pt begins to cough and clear her throat. Patient describes a feeling of "a tickle in my throat." Water offered. No difficulty swallowing observed, patient speaking in complete sentences, no C/O SOB, pt moving air without difficulty. RN assessment reveals lungs sound clear to auscultation bilaterally, no facial edema noted, no flushing, rash hives or wheels noted, no complaints of nausea or abdominal cramping, no C/O dizziness, or feeling sweaty or hot. 1546 Nurse STAT called for further evaluation. Patient's Spo2 100% on RA HR 82. Patient uses her rescue inhaler and coughing and throat clearing increase in frequency. 1554 Patient taken to urgent care for further evaluation and treatment. Patient is a 47 year old female who has completed a14 minute observation period in the vaccine clinic before being moved to the urgent care for an ongoing-minute observation period with the following signs and symptoms of an adverse reaction: other - Cough and throat clearing. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  Action(s) taken: Another drug administered - 25 mg Benadryl IV, 60 mg Solumedrol IV, patient moved to urgent care for further evaluation and treatment. o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o Patient advised to discuss second dose considerations with a clinician   RN
Severe joint and muscle pain starting in the early morning the next day interrupting sleep to pretty drastic pain in all my joints (arms, shoulders, elbows, knees, hips, and back for specific examples) and also with cramping muscles in calves and thighs that have been very tight and tender for the rest of the day. Also experienced lethargy and nausea on the day after the vaccine. I did have GI upset immediately after and for a few hours after getting injection but that subsided overnight and I experienced some neck stiffness within an hour of the vaccine but that seemed to wear off through the day.  As of writing this (10:20 pm) I am still experiencing joint pain but it has decreased as well as muscle soreness; went from a 9 at the worst and is now a 3/4 and better with analgesics
Patient reported 2 hours after receiving the vaccine that she had a red spot on chest, took benadryl and zyrtec. Patient reported 30 hours after vaccine that rash had spread to whole chest, back, arms, and injection site and was hive like. Reports also having vivid and crazy dreams, feeling restless the night before.
Arm where shot was given was swollen and red. Pt went to MD and was diagnosed with cellulitis. MD gave pt KEFLEX.
pt reported pruritus on the L side of neck. Pt reports a h/o of anxiety and self-administered alprazolam.
Face Swelling; Eye felt weird; Soreness behind left ear; Stomach felt like "Someone punched her"; Achy Bones; Tightness on right side of body; Sore arm; Rash on Cheeks and Neck; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her") and BONE PAIN (Achy Bones) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Xanax.  Treatment medication included Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains non significant information. The primary reporter contact details were updated.
Reports dry cough. She stated it is not uncommon to have a dry cough this time of year, not sure if it is related to the vaccine or not  Treatment: Mucinex no change, did not get better nor did it get worst.  Outcome: Remains unchanged, recommend to follow-up with PCP if cough persist. Does not interfere with ADLs.
APPROX 5 CM RAISED, RED, HOT AREA WITH MILD SWELLING OF RIGHT DELTOID AT VACCINE SITE
Itching on my legs. no welts or hives. just itchy skin overnight. when I woke up I did have welts and where any pressure is applied to my skin a welt forms and swells and itches. (example, I held my purse strap on my shoulder and when I put my purse down there was itchy redness and a welt where the strap applied pressure.) These welts are all over my body. Back, under my breasts, legs, arms etc. and one on my face.
Acute right elbow swelling and pain 2 days after vaccination. No recent trauma to the area, no skin changes. Exam notable for exquisite tenderness to right elbow palpation and restricted range of motion due to pain, edema particularly in region of lateral epicondyle and extensor muscles/tendons. Presented 4 days after vaccination for evaluation. XR showed no fracture or joint effusion. Labs showed normal CBC and negative inflammatory markers. Some improvement in edema and pain with NSAIDs. Overall presentation consistent with reactive arthritis.
Headache, Myalgia, Fever, NauseaVomiting, Headache, malaise, Chills, fever, body aches, Shoulder pain, arm pain, Nausea, eye swelling Narrative:
Patient called and stated that she came in on Monday and got a shot. Patient stated that she noticed a lump on her arm, on the area where she got shot. Patient stated that it is not red, not swollen, not warm to touch and she has not had any fevers or chills. She said area was tender to touch.
p/vax pt devel approx 3"x5" redness @ triceps area, felt warm & was tender;afeb;
Fever, pain in eyebrows during the day of 9/2012. Recovered by 9/21/12. No treatment necessary.
3 erythematous plaques about 1 cm diameter occurred 24-48 hrs p/vax  in arm distal to vax site which appears as 3cm diameter erythematous plaques consistent w/sterile abscess;
Patient was seen in physicians office 11/6/18 and received vaccinations; 3 days later had appendectomy procedure performed.
Only information available: patient received mRNA vaccine and subsequently had myalgia.  Reaction listed as: polymyalgia and needed steroid
shot area swollen, shooting pains down arm to hand/ fingers, continuous excruciating shoulder, upper back, and neck pain. treatment-tylenol- ice-heat- icy/hot cream
Red, swollen area, slightly warm to touch 2-3 inch diameter. Soreness in leg. Patient seems ok. Running and playing. No other complaints.
The evening of Sunday, March 28 (4 days after J&J vaccination) my skin began itching on my legs, feet and arms and was extremely itchy all through the night and into the next morning. On the morning of Monday, March 29, a red rash appeared on my legs and feet and arms. It would rise up in one area and then move to another area. I was itching uncontrollably and went to a clinic. I had never experienced any kind of skin condition or reaction like that before. The Nurse Practitioner guessed that it was some kind of allergic contact dermatitis, with the inciting irritant unknown, and gave me a prescription for Prednisone to take over two weeks. By the time I got home the rash and itching had moved to my back, chest and stomach. The itching and rash subsided after I took the first couple doses of Prednisone that day. I finished out the prescribed dosage over the following two weeks. I have not had any more rash or skin irritation since March 28-29.
Flu like symptoms. Sneezing, runny nose, cough, body aches.
had vaccination but got shingles/Suspected vaccination failure; shingles; really hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The case was received from the patient via Interactive digital media. The patient had the vaccination but got shingles. The patient stated really hurts. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The same day as the injection, I started to have severe pain at the injection site. The pain has gradually increased to the point I am now unable to move my arm due to the pain. The pain area has also increased. It is no longer just in the injection site, but also in my shoulder and armpit. I am also having pain in my upper neck, middle back and in my head almost like a headache but not. Additionally, I continue experiencing severe muscle cramps that each last longer than 2 minutes in my legs, arms, feet, hands, stomach and bottom of my chin. My heart keeps fluttering and I am experiencing episodes of sleep paralysis. I'm asleep and I wake up, but I cannot wake up my body. I'm temporarily paralyzed and cannot even open my eyes. Or, I can only open one eye (my right eye, for example). I have developed a cough. I have absolutely no energy. I feel terrible.
Initial misuse report received from a healthcare professional on 27 November 2013 and at agency on 21 March 2014. A '71-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL on an unspecified date, and no adverse event was reported. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Patient received 1st dose of moderna and week and a half ago caught COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID). At the time of the report, COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient was tested positive for COVID together with her siblings and were not contagious. No treatment information was provided.  Company Comment: This spontaneous case reported by patient family member concerns a one-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19, around 3 weeks after receiving a first dose of mRNA-1273.  She tested positive for Covid19 alongside her siblings.  Clinical course and treatment not reported.  Outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637089 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by patient family member concerns a one-year-old female patient, with no reported medical history, who experienced unexpected, non-serious AESI Covid19, around 3 weeks after receiving a first dose of mRNA-1273.  She tested positive for Covid19 alongside her siblings.  Clinical course and treatment not reported.  Outcome was unknown.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637093:Child 1 US-MODERNATX, INC.-MOD-2022-637094:Child 2 US-MODERNATX, INC.-MOD-2022-637089:Reporter case
Tired, nausea, muscle soreness, shivering, mild headache, shivering, stomach pain, low grade temp (99.9F), red, sore, swollen injection site for 3 days.
pain that felt like two golf balls; really thirsty; Felt immune system compromised; bad shivering; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired). At the time of the report, PAIN (pain that felt like two golf balls), THIRST (really thirsty), MALAISE (Felt immune system compromised), CHILLS (bad shivering) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took no treatment.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No new information
every time she got the Moderna vaccine, she got a cough for 7 months; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (every time she got the Moderna vaccine, she got a cough for 7 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Specific product reported as: No, product was inferred.  .     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 COUGH (every time she got the Moderna vaccine, she got a cough for 7 months). At the time of the report, COUGH (every time she got the Moderna vaccine, she got a cough for 7 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
no adverse events; A patinet was administered improperly stored M-M-R-II; This spontaneous report was received from a medical assistant, regarding a 13 months old patient of unknown gender. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 04-MAY-2020, the patient received a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot # S004118 and expiration date was 11-FEB-2021) (strength, dose, route and anatomical site of injection were not reported) for prophylaxis, which was improperly stored (product storage error). Sterile diluent (STERILE DILUENT) (lot # and expiration date unknown by the reporter) used to reconstitute the vaccine was properly stored. The improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) experienced temperature of -58 degree Fahrenheit (F) to +46 degree F with 33.3 F for 17 hours and 30 minutes. The previous temperature excursion was above 47 degree F with 47 F for a time frame of 20 minutes. A data logger was involved. No additional adverse effects reported. No further information was provided.
This spontaneous social media report as received from a registered nurse via a company representative refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The nurse saw the information on the patient's mother's Facebook page. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided). On an unknown date, the patient experienced fatigue, memory loss and numbness in her legs after getting the vaccine. It was not reported how many doses of the vaccine the patient received. On an unknown date, the patient went to hospital for neurology tests and blood work. The reporter did not know if she was admitted or not. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not provided. Additional information has been requested.
DTaP given left leg on 8/6/03. 08/08/03 office visit. Leg is swollen, no fever, redness, numbness. Some pain.
Persistent diarrhea 12-15 x 1 day. Lasting > 2 weeks. All stool studies normal.
Patient because dizzy and nauseous about 10 minutes after his vaccine.  His skin appeared ashen and clamy.  His blood pressure was 78/51.  He refused to attempt to stand up.  We called 911 given the patient's previous history with the pfizer COVID vaccine.  They arrived immediately and his care was turned over to them.