chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a vaccine that had 5 different temperature excursions; No adverse event; Patient received a vaccine that had 5 different temperature excursions; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Patient has no allergy.  Concurrent medical conditions included Asthma (uncomplicated) and High cholesterol.    On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported. No treatment information was provided by the reporter.
Temperature 102.8 degrees Farenheit, warmth and pain at injection site, dizziness
Itching that originally started on arms and chest but moved to legs. It began as mild but became more severe at times. 30 hours after the shot was given was the most severe with swelling of lower legs and a rash. Both arms also ached, especially in the forearm area and wrists. The left arm (where the shot was administered) was more painful than the right arm. Discomfort on the 2nd night after receiving the vaccine made sleep impossible.
Extreme itching and rash over entire body began day after injection and lasted at least 5 days
heavy vaginal /menstrual  bleeding after receiving COVID-19 ( Pfizer ) vaccine  , which required doctor's visit  Menstrual bleeding lasted longer than usual menstrual bleeding
CARDIAC PALPITATION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiac palpitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac palpitation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920683, 20210936884 and 20210937248.
Information has been received from a medical assistant concerning a 59 year old white male who on Nov 9 2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23 polysaccharide vaccine (lot 650084/0605P). the patient also received influenza virus vaccine (unspecified) on the opposite arm. Concomitant therapy included salmeterol xinafoate (severent) and albuterol sulfate (+) ipratropium bromide (Combivent). On Nov 9 2005, the patient developed allergic reaction. On Nov 10 2005, the patient came to the clinic and was treated with antibiotics. The patient was reported as recovered. Allergic reaction was considered to be an other important medical event by the reporting medical assistant (OMIC). Additional information is not expected.
1619 MenQuadfi administeredin right deltoid.  1620: Client reported not feeling well after vaccine administration. Client dropped her head. Client's color became very pale, with blue/purple coloration noted around eyes and mouth. Head repositioned, arms noted to be drawing in towards her body, unable to speak. Moved to the floor by staff. + void noted. EMS called, requested EMS transport.   1621 Client noted to have a heart rate and breathing. Oxygen via nasal canula.   1622 VS obtained: BP: 111/66, P: 127, RR: 24, SPO2: 99%, temp:98.7. Client able to sit up, no verbal response. Moved to room with assistance from staff. Client remained pale in color. Client's mother at the bedside.   1627 EMS arrived in room with client. Care taken over by EMS. BP:113/72, R: 130, RR: 22, SPO2: 99%,.  1635 Client moved to EMS stretcher  1637 Client awake and talking with EMS staff. To ambulance by EMS stretcher.  1640 EMS departed facility en route to Hospital Emergency room
The patient stated she started experiencing pain in her arm at the site of injection of the pneumonia vaccination. She also stated she has difficulty moving her arm when she tries to reach up high. These effects occurred the evening of receiving the immunization on 10/17/17.
C/O onset of rhinorrhea, nasal congestion, fatigue, sinus pain, viselike headache, temp 102 degrees F times 9 days, chills, nausea, anorexia, myalgia,  arthralgias onset of symptoms 48 hours after flu mist.
The following day after receiving the vaccine, I started spotting and cramping. Within hours this became more intense and the bleeding became very heavy. This was outside of my usual menstrual cycle as well as very abnormal for me. I became extremely weak and fatigued. Combined my symptoms lasted for 12days and counting. My doctor eventually prescribed me a very low dose of Provera to take for 5days in order to control the heavy bleeding and hopefully return my cycle back to normal.
Shingle like symptoms on left side of scalp/ face/ neck/ left arm and left torso.Extreme sensitivity to touch/cold/heat on affected side.Left neck muscles sore and aching.
She reports a swollen lymph node on the same side as injection; This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 22Feb2021, as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient reported noticing a swollen lymph node on her collar bone on the same side that she received the vaccine on 04Mar2021. She was due for her second shot, today, but her HCP told her to wait another week to see if the swelling in her lymph node will go down. Do we have information about duration of swollen lymph nodes? Lymphadenopathy is a commonly reported AE in the clinical trials, but the frequencies we have reported are from the 7 days post either dose. No information for duration. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Blotches in both arms; Rash in torso/Blotches in torso; Rash in both arms; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 039K20-2A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MIRTAZAPINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills). At the time of the report, RASH MACULAR (Blotches in both arms), RASH MACULAR (Rash in torso/Blotches in torso), RASH (Rash in both arms) and CHILLS (chills) outcome was unknown.        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 laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of cold in a 53-year-old female patient who received FLUARIX Quadrivalent (batch number XN54L, expiry date 7th June 2018. On 18th August 2017, the patient received FLUARIX Quadrivalent .5 ml. On 18th August 2017, less than a day after receiving FLUARIX Quadrivalent, the patient experienced cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased. In August 2017, the outcome of the cold, shoulder pain, unable to swallow, fatigue and mobility decreased were recovered/resolved and the outcome of the swollen glands was recovering/resolving. The reporter considered the cold, shoulder pain, unable to swallow, swollen glands, fatigue and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The patient received FLUARIX Quadrivalent vaccine in left deltoid. The patient experienced some side effects. The patient was feeling cold and she was fatigued after receiving the vaccine. The patient was tired and she could not swallow. She had a swollen gland and her shoulder was sore and could not move her arm. The patient was feeling better at the time of reporting, but she had a little swollen gland but not as bad as before. The patient was taking other medications, however, the reporter did not want to provided the medication names. The reporter suggested that we could contact and had provided contact details for the same.
Vaccine administered below the deltoid; A spontaneous report was received from  a consumer (patient's husband) concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had vaccine administered below the deltoid.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly below deltoid for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the husband of the patient reported that his wife (the patient) did not receive her shot in the deltoid, but below the deltoid area. No further information was provided.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the events is not applicable.  The event vaccine administered below the deltoid, was considered resolved.  The reporter did not provide an assessment for the event vaccine administered below the deltoid.; Reporter's Comments: This case concerns a female patient of unknown  age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered at inappropriate site without any associated adverse events.
This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 14 days after receiving BEXSERO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not reported. But, it could be 15 or 16 years. The patient's arm was swollen for 2 after weeks of vaccination. The reporter consented to follow up.
Mild/moderate rash on arm around injection site. 5-6 cm diameter. Mild "tight" feeling of skin. Localized. ----note, the immunization data wasn't yet uploaded to pt's chart---call to get info when/if you needed it, I'm not sure exactly which influenza vaccine was given, but it was influenza. Minor local rxn.
After the vaccine was administered, she decided to check her pulse and see that was a little high, get scared.  She was evaluated by the Fire Rescue at 10:30 am and was released home at 10:45 am.
Burning sensation on upper right back which moved to shoulder and right front upper chest. Elevated blood pressure. Went ER on 01292021. Resolved on own by 01312021
arm twitching after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (arm twitching after my vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (arm twitching after my vaccine). At the time of the report, MUSCLE TWITCHING (arm twitching after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue, and echimosis in left elbow, down to hand.  (Vaccine injected into Right arm IM.)  Pt. was not seen by doctor until 11/17/2003.  Vital signs at time of Dr. Visit BP 144/70, T 97.0, P 84, R no info.
Patient vaccinated with Proquad on 10/17/06.  On 10/27/06 patient started with fever and rash which started on the hairline.  The next day the rash spread to the face and torso.  By day two the rash was from head to toe.  The rash did start to resolve on day three.  The patient also had watery eyes and runny nose.  Mom notified physician on 10/27/06.  No treatment was given.
This spontaneous report as received from licensed practical nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (strength, dose, unit, route, lot# and expiry date unknown). On an unknown date within 24 hours of the administration, the patient experienced insomnia and severe headache. Patient called to office to report the events. The outcome of insomnia and severe headache was unknown. No further information provided. Additional information has been requested.
Hard red indurated area in proximity to both injection sites monitored over two days through urgent care - Phone visit with mother 3/17/08 states much improved and redness resolved.
Initial report received on 31 January 2012 from the investigator under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had previously received 3 doses of PENTACEL on the following dates: 21 January 2011, 21 March 2011 (lot number not reported) and lot number C3872AB on 23 May 2011 (route and site of administration not reported). The subject developed a cough on 11 December 2011, approximately 7 months after the last dose. On 24 December 2011, the subject developed a paroxysmal cough with posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 11 January 2012. Chest x-rays findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 11 January 2012. The subject was not hospitalized. At the time of final contact on 18 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 38 days. As per protocol, no causality assessment provided by investigator. Documents held by sender: None.
Soreness at the arm where the injection was; soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Aug2021 (Lot number: EW0165) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Soreness at the arm where the injection was"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "soreness in the arm".  No follow-up attempts are possible. No further information is expected.
Received moderna booster shot (Had J&J on 8/2021) on 12/28/21 approximately at 10:45am. At 7:00am woke up to numbness and tingling. Swelling started approximately at 2-3:00pm. Went to ER. Was seen by ER MD. He felt this was a reaction to the vaccine. Notified facility to let them know events. Was given IV Benadryl at ER about 5:30 PM and was sent home.
Patient has no history of adverse effects with vaccines and was on the 3rd dose of the pfizer covid vaccine. She recieved her vaccine and seemed okay and was instructed to wait 10 to 15 minutes in case there is an adverse reaction. I do not know if she chose to wait or not but was informed later that she crashed her car and stated it was due to obtaining a reaction from the vaccine. Further details are unknown as the patient did not report back to  the pharmacy and did not answer a phone call from me today (10/24/21)
At first it was the usual pain in arm, muscle aches, and fatigue, then within a day or two I started getting cysts on my face and little bubbly and itching patch on my arm, then I started feeling really lousy and sweating and hot sensations all over-like I was standing in front of an oven-, and itchy more than usual. I also started getting a sore throat and runny nose. Now this morning I woke up to find tiny pustules all over my face.
Evening after vaccine was given, patient started experiencing rash and itching starting at chin and extending down her neck. No wheezing, shortness of breath, tongue swelling etc. Patient was given Benadryl with mild improvement of symptoms. Father called office and was instructed to continue Benadryl every 6-8 hours as needed and to follow up following day (9/16) . On 09/16, mother sent updated picture of rash and was much improved. Parents concerned it was related to HPV immunization.
This spontaneous report as received from a medical assistant regarding to a 19-year-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 26-JUL-2018 the patient was vaccinated with VAQTA 25/0.5 (lot # R006209; expiry date: 16-MAR-2019), at a dose of 0.5 milliliter for prophylaxis (incorrect dose administered). No adverse effects (no adverse event) reported. No additional information provided.
pt recvd vax; swelling at site of inject; nausea,vomiting; fever; ha & backache;
Swollen lymph nodes along left jaw line and side of throat. Later about 4-5 days
Delayed reaction:  severe Headache, fatigue (day 8). Started at noon and felt fine the next morning
Extreme pain in both knees and lower back.  Fuzzy vision.  I can barely walk.
The evening of the vaccine reports severe headache and very sore arm. Nose bleed (not severe stopped w/o medical intervention.
Swelling of upper lip; slight skin rash; itchiness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A), via an unspecified route of administration, administered in left arm on 08Sep2021 09:30 (at 72-year-old, non-pregnant at time of vaccination) as dose number unknown, single for covid-19 immunisation. Vaccine was received in hospital. Medical history included low thyroid, high blood pressure, cholesterol. Known allergies: Penicillin. No COVID prior vaccination. The patient's concomitant medications included other medications in two weeks. No other vaccine in four weeks. The patient experienced swelling of upper lip and slight skin rash, itchiness on 10Sep2021 at 12:00 AM. The events resulted in emergency room/department or urgent care. No COVID tested post vaccination. Therapeutic measures were taken as a result of the events included steroid shot along with antihistamine shot. The outcome of the events was recovered on an unspecified date.
Headache, severe diaphoresis followed by chills with repeats of the cycle.  The following day the headache continued with difficulty regulating body temperature.  Joint aches and muscle weakness followed.
Vaccine was not diluted prior to administration. Recipient has a sore arm with no redness or swelling, headache and sweaty. Recipient did not require further treatment.
Increase in blood pressure and heart rate, slight shortness of breath. (Within 5 minutes of shot) (passed in about 30 minutes) Weakness and slight fever the following day.
Headache, Myalgia, NauseaVomiting, fatigue h/a myalgias n/v chills Narrative:
On 01/31/2023 I had a sore throat cough and difficulty breathing . After testing positive for Covid-19 pneumonia  I went to the hospital for two weeks and prescribed Paxlovid.