chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents with swelling and redness on right arm from the injection site. Also experienced nausea and cellulitis. Patient treatment = ice the area frequently, start on BACTRIM ABx and return to clinic to follow up on treatment, if it is helping.
Severe muscle aches in shoulders, chest, back & neck; severe chills; fever (up to 100deg); headaches; head & neck pressure; total loss of appetite.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old male.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
13MAR91 pt 2nd vax; exp Hepta B surface antigen = positive & hepta B disease.  ER visit required.  16Mar91 exp n/v, malaise, jaundice.  Gallbladder wall thickening suggest chronic cholecystitis.  See worm...
In the evening, the day I got the vaccine, I started feeling body aches all over. The arm that got the vaccine hurt the most, as to be expected, and there is a knot in the muscle where I got the injection. I have felt pain all over since then. It has not been touched by naproxen sodium. A cold shower gave temporary relief.
pt recvd vax & had t 103 x 4 days seen in ER 19AUG t100; 25AUG WNL;
Patient was given a 3rd dose of Pfizer 4 days after receiving her 2nd Pfizer dose. Attempted to call patient to advise her of the vaccine administration error, unable to reach patient. Left detailed message requesting a call back.
Rash. The problem is new. The current episode started 6 days. Since onset, the problem has been gradually worsening. Affected locations include left arm, torso, abdomen, groin and left upper leg. Symptom characteristics include redness, papules, itchiness and burning (Papular rash present to groin. Skin tender to touch. Irritated with clothes). Associated symptoms include myalgias. Negative for non-blanching rash, fever, rhinorrhea, shortness of breath, headache, anorexia, congestion, joint pain, sore throat, stiff neck, malaise, cough, diarrhea, swollen glands, vomiting, nail changes, facial edema, fatigue and painful lesions Tetanus is up to date. PMH includes MMR series and varicella series. Negative for diabetes, eczema, immunocompromised, MRSA, psoriasis, strep, asthma, and allergies.
This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 7th October 2018, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on unknown arm. The batch number was not reported. The patient was experiencing tingling in the unspecified arm that the injection was given. The tingling was from the wrist up to the injection site area. The tingling was intermittent throughout the day. The only relief the patient experiences from the tingling was when she places her arm over her head. The onset of symptoms was not known. The reporter consented to follow up.
4 pts recvd Engerix-B & on 7AUG91 & immediately upon inject devel dizziness, weakness & fluctuating BP;
Sleepy, tired, sore arm over the course of 1 week after booster vaccine with it still ongoing
Left arm pain leading to chest wall pain with pmhx of angina. 6/10 pain radiating to left neck, SOB.
the patient sure get sick everytime he/she give in and take one; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 10-Oct-2020.  This case was linked to case 2020SA294157.  This case involved a patient of unknown demographics who sure get sick everytime he/she give in and take one (illness), while he/she received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history, were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that he/she surely get sick everytime he/she gave in and take one (illness), (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was the patient sure get sick everytime he/she give in and take one.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.
Large Rash/Hives on forearm of left arm. And upper chest Lips swelling
Patient felt lightheaded and fainted while exiting the store. Patient did have bleeding at injection site.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was not reported previously to anyone. The patient experienced dizziness and continued to have the issue. He had not notified his physician yet.
Headache; back and spinal cord was certainly bad; back and spinal cord was certainly bad; This is a spontaneous report received from a contactable consumer(patient). A male patient of un-specified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168), via an unspecified route of administration on an unspecified date as unknown, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date it was reported that patient took the Pfizer shot about a week ago and patient had a headache all week and patient's back and spinal cord was certainly bad. Patient was provided with the number of Pfizer Medical Information. When probed to see if patient needs any medical assistance, patient stated that's why patient was calling, patient did not know. Patient was unwilling to share further information hence product details (Expiration date, NDC#, UPC#) reporter type and other details were unknown. The outcome of events was unknown.
Patient given 2 month-old immunizations - while being given the vaccinations, eyes rolled back, went limp, pale - lasted a few minutes, by 20 minutes of observation was back to base line. This is our second similar episode - the first was in a 6 month old receiving PEDIARIX/HIB/PREVNAR.
He had an allergic reaction to the first dose of Pfizer's COVID vaccine; He has been sick for 3 months; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had a historical vaccine of Flu vaccine for immunisation and a allergic reaction. The patient reported he had an allergic reaction to the first dose of Pfizer COVID vaccine. The reporter had assumed it may have been due to the PEG/polysorbate 80 allergic reaction, which is why he has been sick for 3 months. The allergist offered to give the second dose of the vaccine in small doses. Medical history included allergic reaction to the flu vaccine. The Patient was advised to speak to his HCP with regard to test for allergic reaction to Polyethylene glycol. Relayed PMI number but advised no listing of where to get tested, Medical Information can only answer medical questions. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tongue and face tingling; Numb tongue and face; Mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction). At the time of the report, PARAESTHESIA (Tongue and face tingling), HYPOAESTHESIA (Numb tongue and face) and HYPERSENSITIVITY (Mild allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Severe dermatological RX of Hives and severe itching on both sides of my face about 12 hours after Hep B vaccine. From employee health office at hospital where I work.  Still current on 07/24/216.
Child was given vaccines on catch up schedule. Child was screaming and father restrained child for administration. Child screaming throughout injections. Father dressed child pants and coat and took her to waiting room still screaming. Finished documentation and scheduling with mother child & child became limp and eyes rolling back. Brought child to exam room extremely pale diaphoretic and pulse and HR strong & Breathing. Stimulated child not responding took coat off and cool cloth to head, ice pack to back & stimulated talking to child occasionally eyes open slightly. Called 911. Heart decreased and bicycling legs. Color remains remains very pale and skin clammy refused any water given a sip water later. Child slowly woke up but muscle tone was poor and color pale although lips are finally a pale pink vs white. Taken to ER for evaluation discharged by 4pm. Called mother @ 4:39 to follow up. Child alert & talking but now feeling she is getting tired. Dx with vasovagal reaction per ER. Plan to f/u with PCP.
Headache  Sneezing  Runny nose Watery eyes  ALLERGY SYMPTOMS THAT LASTED ONE DAY
A few seconds of the injection I experienced moderate light headedness which resolved quickly.  The following morning I began experiencing moderate aches and pains, generalized malaise which resolved quickly with Tylenol.  As the progressed, the achiness and increased and did not resolve quickly with Tylenol.  By 2:30 pm that day, I experienced chills that did not stop, and pain in the bones of my legs that felt like flashes of extreme heat, especially on the femur.  I began experiencing nausea. That night I was unable to sleep more than 3 hours.  Around 1 am of January 27th I began feeling chills, and pain once again.  I took Tylenol, and after a short while I began sweating.  Generally, the pain, chills, and burning sensation stopped that morning, however the nausea continued through the day, especially after trying to eat.
HEART INFLAMATION, PT IS CURRENTLY IN THE ER. PT'S MOTHER CALLED TO INFORM US.
Hives on chest/neck, armpit area. Took a Benadryl and mostly went away. Hives reappeared 48 hours later--chest, arms, stomach, back. Gave Benadryl again. No additional symptoms.
Initial misuse report received from a nurse on 02-OCT-2013. The patient had received last year's FLUZONE (dose unknown). No adverse event was reported. List of documents held by sender: none.
Information has been received from a consumer concerning her daughter with no past medical history or allergies, who on an unspecified date, 5 days before her first birthday, at the age of 11 months, was vaccinated with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. she was vaccinated four months later, at the age of 15 months, with a second dose of measles virus vaccine live + mumps virus vaccine live +rubella virus vaccine live.  There were no concomitant medications. It was reported that the patient's "measles vaccination was low" when she was tested through a titer. It was determined that she was fine on mumps and rubella, but her measles was low. The physician did not give the mother a specific number to rate how low the titer was. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. Additional information has been requested.
No adverse effects. Engerix dose approved for 20 years of age and older and he is younger than that. Should have received pediatric and adolescent version
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 15:30 as dose 4 (booster), single (Lot number: GJ3275) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetic" (unspecified if ongoing); "prior surgeries like gastric bypass in 2013. No other surgeries have lasting effects.", start date: 2013 (unspecified if ongoing). Concomitant medication(s) included: AMBIEN CR; ZOLPIDEM TARTRATE. Past drug history included: Roxicet, reaction(s): "known allergies: Roxicet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Skin sensitivity, bad taste in mouth, those both went away after completing Paxlovid treatment. Was starting to test negative but am now testing positive again. Had a slightly irritated throat. Patient received paxlovid for covid 19 treatment, started on 07Nov2022 and stopped on 12Nov2022.
feeling of numbness over the left side of the face; Developed swelling over the left side of the face; Developed swelling over the left side of the lips.; Feeling of numbness over the left side of the lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (feeling of numbness over the left side of the face), SWELLING FACE (Developed swelling over the left side of the face), LIP SWELLING (Developed swelling over the left side of the lips.) and HYPOAESTHESIA ORAL (Feeling of numbness over the left side of the lips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (feeling of numbness over the left side of the face), SWELLING FACE (Developed swelling over the left side of the face), LIP SWELLING (Developed swelling over the left side of the lips.) and HYPOAESTHESIA ORAL (Feeling of numbness over the left side of the lips). At the time of the report, HYPOAESTHESIA (feeling of numbness over the left side of the face), SWELLING FACE (Developed swelling over the left side of the face), LIP SWELLING (Developed swelling over the left side of the lips.) and HYPOAESTHESIA ORAL (Feeling of numbness over the left side of the lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medications were not provided.
Tingling, numbness and a bad burning sensation that wouldn't go away.  Started to go up hand to lower arm, but then prescribed STEROIDS to calm down.  Burning sensation subsided, but not numbness in fingers.  Carpal Tunnel surgery required. Fingers still numb.
7-8-15 had severe upper back pain, unable to move (L) arm, muscle aches. 7-11-15 c/o (L) deltoid is hard, red, tender to touch with chills.
Patient at clinic with parents for Pfizer Bivalent booster vaccine.  Pfizer Bivalent Covid-19 vaccine was administered without being diluted.  Event also reported to Pfizer Manufacturer Safety Team and recommended not to give covid-19 vaccines for now. If patient reacting well may receive more doses within recommended schedule at discretion of pcp.  Recommended provider and parents to monitor patient and intervene accordingly.
chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101225741 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 07:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 17Sep2021 13:00, outcome "unknown", described as "chills".  Additional information-It was reported that she took the 2nd shot this morning, around 07:30, and she takes care of kids after school and its noon, 1pm where she was, and she's starting to get the chills, she really doesn't feel bad. Her concern is can she have an effect on the kids around her after having the second dose? She just started with the chills about an hour a go, she's been fine until then, she's just concerned about the kids and the people she works with. She just wants to know even if she does have chills, they don't have them going to work if they have Covid, they check them, so it kind of gave her Covid right. She just wanted to find out if she should go to work today or stay home. She also has an aging mother, that's why she got the darn thing. She's been healthy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lymphedema after vaccine; Arm blew up; Her arm blue up really big; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big). At the time of the report, LYMPHOEDEMA (Lymphedema after vaccine), SKIN DISCOLOURATION (Arm blew up) and PERIPHERAL SWELLING (Her arm blue up really big) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included blood pressure medication.  Patient experienced lymphedema after her first dose and she started the lymphedema therapy.   This case was linked to MOD-2021-292652 (Patient Link).
pt reports redness/swelling & warmth to rt arm extending from elbow-shoulder;began 25OCT98 & has swelling on 28OCT98;seen by MD 27OCT98 no tx prescribed;
Febrile Seizure. Only other symptom leading up was a rash and mild diarrhea. EMS took to ER. Pt discharged.
Several days after the shot I developed bright red itchy spots on my inner thighs and buttocks. Now, almost 3 weeks later, the thighs are fine but the spots still cover my buttocks. I?d guess a dozen per buttock. Unfortunately I have been scratching at them. My second dose will be Apr 13.
2-3in in diameter raised reddened area w'itching & hot to touch @ the site of inj;localized rxn lasted 5 days;
Swelling and pain experienced  in lymph nodes near right arm where injection was administered. Currently  going through lymphodema therapy as part of cancer recovery.  My left lymph nodes were taken out during mastectomy operation, so right arm is the viable option for an injection site
reported by mom-vax given 30DEC93 & did well; hurt finger 1JAN93 began crying, suddenly stopped or coudn't cry, seemed to stop breathing & turn bluish; gave 2-3 breaths mouth to mouth & recovered;
General unwell feeling for 24 hours, fever night sweats within 8 hrs of shot lasted about 14 hours.  Covid arm severe swelling and itching at injection sire 24 hrs later, 2 to 3 inches wide si far and im 48 hrs post vaccine.
breast tenderness; lump in armpit; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit). At the time of the report, BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.