chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to pharmacy on 05/12/21 for second Moderna dose. While filling out VAR, she noted that she did have an adverse reaction to the last dose. When asked, she stated she developed a red, bumpy rash all over the side of her body about 4-5 hours after receiving the vaccine. She declined itching, noting that it was just red and swollen, and took ~5 days to go away. She declined shortness of breath or difficulties breathing, but did note her throat felt tight. She did not take any medications and had not mentioned it to anyone until now. Due to the non-severe immediate allergic reaction, the CDC recommends not giving the second dose. Recommended the patient does not receive another dose.
Pt has erythema, pain and swelling ~ 2" circumference surrounding injection site.
Information has been received from a health care worker concerning a 44 year old female patient with hyperlipidaemia who on 05-SEP-2007 was vaccinated with a dose of PNEUMOVAX, lot #655765/0061U.  Concomitant therapy included CRESTOR.  The patient reported fever and swollen lips and the injection site area was red and swollen starting on 07-SEP-2007.  The patient was instructed to take BENADRYL for symptoms.  She was seen in the office of 11-SEP-2007 and was given a prescription for a MEDROL DOSPAK.  The patient was reported to be recovering.  The doctor's office has requested a lot check for PNEUMOVAX lot #655765/0061U.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the research center and was released.  The reporter indicated there were 2 other patients who also had injection reactions after vaccination with PNEUMOVAX.  Additional information has been requested.
pt recv vax 7SEP95&26DEC95 pt devel diffuse herpes zoster rash over lt arm;skin biopsy was inconclusive;rash was treated w/hydrocortisone&cont to get worse;
Feeling tired; Groggy; Sore arm; Nauseated; Warm; feel like zombie; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Feeling tired), SOMNOLENCE (Groggy), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseated) and FEELING HOT (Warm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Jan-2021, the patient experienced FATIGUE (Feeling tired), SOMNOLENCE (Groggy), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseated), FEELING HOT (Warm) and VACCINATION COMPLICATION (feel like zombie). At the time of the report, FATIGUE (Feeling tired), SOMNOLENCE (Groggy), PAIN IN EXTREMITY (Sore arm), NAUSEA (Nauseated), FEELING HOT (Warm) and VACCINATION COMPLICATION (feel like zombie) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly male patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site lump, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site lump, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site lump, injection site warmth and fever to be related to SHINGRIX. Additional details were reported as follows: The wife of the patient was the reporter. The patient experienced injection site reactions consisting of redness, warmth and a lump at the injection site. The patient also felt feverish.   The patient had denied permission to contact their physician. Could not obtain all adverse event information caller hung up on the representative when the representative told her we could not provide medical advice about symptoms.
Then why do I keep getting it??? The flu!!; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unspecified gender and age) who had flu (influenza) while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had (influenza) (non-serious).  No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-13007, MOD21-13175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-13007:Crosslinked: Same reporter MOD21-13175:Crosslinked: Same reporter
"I" in this synopsis: I was noti?ed on 3/2/2021 during the P?zer 1st Dose clinic that Patient wanted to report an issue receiving his vaccine administered by MSN LPN.  I interviewed patient who stated he was injected twice during his vaccine administration. He was concerned that he may have been poked with a dirty needle and then given the actual vaccine. He stated that LPN administered the ?rst syringe when he commented that it burned. He stated LPN told him there wasn't anything in that one and then administered the actual vaccine. Patient showed me his arm where it did, in my opinion, appear there were two needle marks in his deltoid region.  I discussed the issue with LPN. Her story was inconsistent as she repeated what happened. She stated she did not inject the patient twice. She denies using a dirty syringe on the patient and stated she immediately throws her dirty needles in the sharps container.   I interviewed LPN a second time with another person present. LPN initially stated she did not inject patient twice. She later stated that she did poke patient twice: The ?rst time is when patient complained it burned. LPN stated she pulled the needle out and then proceeded to use the same needle and injected the patient with the same needle. I informed nurse that I advised against that practice and that her story had changed from the previous versions. I informed her I was sending her home immediately.
left arm broke out in bumps and was sore; left arm broke out in bumps and was sore; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 25Feb2021 16:00 (Batch/lot number: EN6202), at age 58 years old, as dose 1, single, for COVID-19 immunisaiton, at a pharmacy/drugstore. The patient was not pregnant at the time of vaccination. Relevant medical history included diabetes and high blood pressure both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included insulin from an unknown indication, not reported if ongoing or not. The patient did not have other vaccines in four weeks. On 26Feb2021 02:00, the patient's left arm broke out in bumps and was sore. The events resulted to physician's office visit. The patient did not receive treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
RASH ON RIGHT CHEST-UNDER RIGHT ARM AND RIGHT SHOULDER.  TURNED TO BLISTERS.  WAS GIVEN FAMCICLOVIR 500 MG ON 09/10/2011 FOR 7 DAYS BY URGENT CARE NURSE.
Patient experienced arm pain day of injection then had flu like symptoms for four days after- fatigue, body aches chills along with dizziness.
Breakthrough COVID infection. Presented to hospital for fall. Positive test collected on admission. Patient required intubation and mechanical ventilation beginning 09/07/2022.
Immediately after 2nd half of nasal mist, child vomited at least 6 time, and then fainted. Responded after smelling ampule of ammonia and placed in supine position.
Information has been received from a health professional concerning a female who was vaccinated on unspecified dates with the first and second dose of GARDASIL (lot#'s not reported). Subsequently the patient fainted after her first dose of the vaccine. She did not faint after the second dose was given. Subsequently, the patient recovered from fainting  and sought unspecified medical attention. Additional information has been requested.
Pt given 1st dose of HPV and immediately after receiving inj. pt states she felt lightheaded and was put in prone position. Pt became rigid, eyes rolling back and no response from pt., color pale. Dr summoned to room. No response to smelling salts - pt incontinent of urine. Pt regained consciousness and was taken by ambulance to hospital.
After receiving a Td shot patient experienced shortness of breath and muscle spasms.  4 days after she experienced some chest pain which led her to the hospital, where she was told it was not her heart.  Patient is still experiencing chest pain and shortness of breath and her doctor sis not know what to prescribe her to help alleviate the pain.  Now she can only walk short distances as she gets out out of breath.  Follow up on 10/31/2006 and 11/01/2006: Two attempts have been made to contact the patient.  Both unsuccessful as the number is temporarily disconnected.
Patient woke up the following morning of her vaccine with redness, swelling, and warmth at the injection site. She reports that the swelling was greatest when she woke up and decreased slightly throughout the day. She came to the pharmacy to allow the pharmacist to examine her arm at about 8:50 pm on 10/5/21. The pharmacist confirmed that it appeared to be an injection site reaction and recommended she ice the area and take diphenhydramine. The patient returned to the pharmacy on 10/9/21 and stated that the reaction was completely healed.
1.8ml of diluten was not administered to the vial of Covid  19 Pfizer vaccine, it was not capped.  The medical assistant giving the vaccine did not notice that it had not been diluted and gave the entire vial to the patient.  She did not file the process of giving the vaccine.
vaccine was administered after the temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine was administered after the temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment and concomitant medications were reported   Storage condition at the time of the excursion was Refrigerated storage  Total duration of excursion reported as less than 2°C between 1/6/2022 and 1/20/2022: Lowest temperature recorded 0.5 Celsius only on 1/6/2022 at 0801 for 5 minutes.  Total duration of excursion greater than 8°C between 1/6/2022 and 1/20/2022: Highest temperature recorded was 8.8 Celsius  only on 1/14/2022 at 0800 for a total of 5 minutes
Headache began around 8:00 pm on the day of the vaccination with worsening arm pain. The next morning around 7:00 am I had a fever of ~102 F, worsening headache, and nausea.
At approximately 1430, PHN relieved PHN to lunch from her vaccine monitor duties. PHN saw Moderna LOT: 011F21A vial #2 tally sheet and saw that 10 doses were pulled. PHN drew the remaining 10 Moderna doses based off the tally sheet. At approximately 1710, patient arrived to facility requesting a Moderna booster dose. There was 1 Moderna booster dose left from Moderna vial #2. Patient was dropped in as a walk-in, patient was given the last Moderna booster dose, and vaccinator verified correct dose and patient. Upon end of shift report, PHN noticed 21 patients listed on Moderna vial #2 POD participant form and notified Lead RN. Both PHN and Lead RN  cross checked all patients who received Moderna on Calvax and SDIR. All 21 patients received the correct Moderna dose. PHN notified Supervisor, who advised for completion of IR, VAERS.
sore arm; redness; sharp on and off headache; A spontaneous report was received from a consumer concerning a 39 year old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced Pain in arm, Redness, headache.  The patient's medical history and concomitant medication were not reported.  12-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route of administration for prophylaxis of COVID-19 infection.  On 12-Jan-2021, The patient experienced Pain in arm, Redness and headache. No Laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events Pain in arm, Redness, is recovered and headache is Unknown.
Swollen Supraclavicular Lymph Node.  It was roughly 5cm x 3cm. Elongated, moveable, and slightly painful. Lymph node is going down in size, although not totally back to normal size as of 6/23/2021.  It is currently 2cm x 1cm.
GBS devel approx 3 wks p/vax plasmapheresis;
Patient received second dose two days apart from 1st.  1st dose given at nursing home.  Patient had no symptoms.  Communication issues resolved with the nursing home.
Broke out in hives on arms and legs 1-2 hours after injection. The next day had swelling, redness around the site.
Developed a mild case of the chicken pox 12 days after injection. Started developing blisters, about 10 on back, head and arms.  Otherwise no other symptoms and acted normally.
Flu shot 10/18/05, 12/8/05 about 3 days with 2nd dose hives on stomach/neck.  zero trouble breathing.
I was positive for COVID-19 on 18FEB2023, I was very achy and tired, coughing a lot and I had a hard time breathing. I had a very sore throat, congested and very stuffy. I contacted my doctor and she prescribed me PAXLOVID. Even after taking the medication I still was feeling terrible and I wasn't getting any better, she than prescribed me a steroids medication and started feeling a bit better.
Vaccines were administered following a temperature excursion; No adverse event; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T030707, expiration date: 14-APR-2023 (dose number, dose and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA001290: US-009507513-2110USA003605: US-009507513-2110USA003604: US-009507513-2110USA003603: US-009507513-2110USA003602: US-009507513-2110USA003601: US-009507513-2110USA003599:
Patient reported immediate discomfort described as pain and tingling in the elbow. Patient pulled away from the needle during administration.
a big round red mark appeared on her arm; a little swollen; hot and a little sore; a little soreness on her arm /soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm), ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm). On 07-Feb-2021, the patient experienced ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore). On 28-Jan-2021, PAIN IN EXTREMITY (a little soreness on her arm /soreness on her arm) outcome was unknown. At the time of the report, ERYTHEMA (a big round red mark appeared on her arm), PERIPHERAL SWELLING (a little swollen) and FEELING HOT (hot and a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In addition to above mentioned patient also takes High blood pressure medication, antacid and over the counter medication for allergies. No treatment information was provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H015826 and expiration date 24-AUG-2014 (strength and route not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site induration and injection site lump. On an unknown date, the outcome of the injection site pain, injection site induration and injection site lump were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site induration and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient reported only partial information. The patient received SHINGRIX in the left deltoid. The patient experienced soreness at the injection site and hard knot at the injection site. The patient was transferred from GlaxoSmithKline's vaccine patient assistance program. The patient had denied permission to contact their physician.
did not respond to PPV23; Literature Report:   This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 37-year-old female  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose , lot #, expiry date, and route of administration were not provided). On an unknown date, the patient did not response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). At the time of reporting, the outcome of the event was not known.   The event  was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2206USA005089:
T102, spots on arm-redness swelling of upper extremity 4 days duration-no tx given;
A day or so later, erratic heartbeat detected, ranging from low (58) to high (110) within seconds of each other. After several days of continuing erratic pulse, saw family doctor and reported same to cardiologist. Doctor did EKG revealing I had gone back into AFIB after a ten year absence. 5/14/2108 Doctor prescribed increase aspirin dose to 325 from 81, and Diltiazem CD, 120MG capsules, 1 per day. Too soon for results. Pharmacist believes shingles vaccine triggered cardiac reaction, citing body's immune system reaction, and is hopeful condition is temporary. Pharmacist strongly urged me to report this to VAERS.