chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment  was made. There had been no power outages that would have impacted the Moderna vaccine. However, reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.   Reporter stated that no adverse reactions were reported by any patients. No treatment information were provided.
This spontaneous report as received from a medical assistant (M.A) refers to a male patient of unknown age. Concomitant medication, pertinent medical history, drug reactions and allergies were not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscular, lot # K007773 expiry date 01-MAY-2015, (dose was not reported), that had been improperly stored, No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
On 05/08/22 developed intense pruritus at fingertips and DIP joints, progressing to palmar aspect of hands at joints; then periorbital, perioral itching, minimal edema; progressed then to forehead and upper arms/deltoids (B) pruritus. Patient has self-administered oral diphenhydramine 25mg TID and topical hydrocortisone 0.1% for some relief. Seen in clinic 05/19/22 and continued pruritus treated with methylprednisolone 4mg tablet taper (12mg x4days, 8mg x4days, 4mg x4days).
Patient described chest tightness about 15 minutes after getting vaccination and back tightness about 25 minutes after getting the vaccination.
On 7/26/00, pt became very ill. He experienced severe headaches, chronic fatigue, erratic body temperature that spiked as high as 102F and dropped as low as 94F, nausea and complete loss of appetite. His PMP was unable to pin point the cause of the symptoms. He prescribed a general antibiotic while he tested for sinus infections and parasitic diseases. The antibiotic seemed to treat the mystery illness and he got well. He relapsed on 8/21/00, recovered and relapsed again on 9/5/00. On 9/11/00, he suddenly lost his vision in his right eye. He was immediately referred to a retinal specialist who dx'd him as having macular damage and swelling to the optic nerve. He under went a battery of blood test in which nothing was found and was given an MRI which also found nothing. His vision has since returned to almost normal and he had had no further relapse of the mystery disease. We have no idea what caused this 2 1/2 month ordeal. None of the tests run by any of his doctors have revealed a cause. We are now working with others to investigate the possibility that his vaccines may have triggered the illness.
Booster received instead of full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster received instead of full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster received instead of full dose). At the time of the report, ACCIDENTAL OVERDOSE (Booster received instead of full dose) outcome was unknown.     No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-608531 (Patient Link).
Fever, chills, headache, foggy thinking, body aches....lasted over 72 hours
Next day post vax, the pt noticed swelling of left arm around triceps area. Area was swollen, red, and blotchy but child was not complaining. Advised parents to treat with acetaminaphen and cold packs to swelling. On 7/19, the parents called and reported that the swelling was whole arm from wrist to shoulder. No redness except back of upper arm. Advised to see physician in ER and treat with Benadryl, acetaminaphen and cold packs.
She received seasonal influenza shot in the right arm on 9/21/09 in AM. That evening her right arm was sore as it usually is after a flu vaccine. It is painful when she puts her arm behind her and reaches for things. 5 on pain scale of 0-10. The pain shoots toward her elbow. In addition, she indicated a cough and runny nose. On 11/03/09 pain, moderate to severe, was still noted.
Red area near but not at injection site approximately 2 inches wide  by 4inches long (rectangular) with scattered red dots, flat, not raised, very itchy .  Became noticeable on 2nd day after injection, continued until early on 5th day after injection, by end of 5th day nearly faded away and no longer itchy.
23rd: late evening started having chills.  24th: woke up with a sore throat & fatigue. Worsening throughout the day. Started getting congested late evening. Took about 10 menthol lozenges.  25th: sore throat & fatigue persisted along with congestion. temp 100.4. Went for a Covid test. Took 2 doses of sudafed and 1 dose Advil cold and sinus.  26th: woke up with 101.4 temp. Sore throat is now gone, but fatigue and congestion remain. Covid results negative. Took Tylenol.
PATIENT WAS GIVEN FORMULATION FOR THOSE 12 AND OLDER, NOT 6-11. MOM SAYS NO SIDE EFFECTS AT THIS TIME
Pt called on 4/13/13 complaining of pain at injection site, and returned to store on 4/15/13 with what appeared to be a localized allergic reaction.  At the site of administration, patient has a red, puffy welt that was approximately 2 inches around.  Pt complained of an itch and pain associated with the welt.  She was instructed to take some Benadryl and Naproxen to address the itching and pain. Pt instructed to call pharmacy or physician if condition worsens, will be followed up with in a few days.
DIZZIER ON DAY 3, NUMBNESS (PENS AND NEEDLES) IN FEET AND LEGS ON DAY 2, WAS EXTREMELY TIRED FOR 7 DAYS
1st dose had bad hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "recovering", described as "1st dose had bad hives". The event "1st dose had bad hives" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information included: The patient had no covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Fever of 101.5, rash on bottom and red itchy where shot was administered.
Information has been received from a physician concerning an 85 year old male who on 08-APR-2008 was subcutaneously vaccinated with ZOSTAVAX (Merck) (dose and lot# not reported). On 26-MAR-2009 and on 21-DEC-2010 the patient experienced shingles two times within four years of receiving ZOSTAVAX (Merck). It was unspecified if the patient sought medical attention. The patient was treated with VALTREX. At the time of reporting, the outcomes were unknown. Additional information has been requested.
This spontaneous report as received from a consumer refers to her 78 years old husband with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ "4 years ago", in October 2008. No other co-suspects were reported. Concomitant medications included unspecified other medications. The consumer reported that "3 months ago", in July 2012, the patient experienced pain over his right back and ribcage, and on his left neck and ear. The consumer stated that the patient had this pain for 3 months and it currently being treated with acetaminophen, VICODIN for the pain. The treatment was working however the symptoms occurred frequently and especially after eating. There were no Lab diagnosis or studies performed. Additional information is not expected.
immediately after patient  had injection administered she fainted. The pharmacist that administered the Moderna was still seated right beside her still and patient was seated. The pharmacist gently lowered patient to floor and called for help. I called a code white and went to patient. Pt was disoriented and hot. Gave her an icepack and had management get her a water. After several minutes she was no longer disoriented and was embarrassed. She said "she is a baby" and just freaked out a little. She said she was on lunch break to get the shot and had not eaten lunch. I offered to get her something to eat but she refused. I contacted someone to come pick her up since I didnt want her to drive after being disoriented. I also called her boss to let her know she would not be coming back to work per her request. I followed up with her and she said she was feeling perfectly fine and completely over the inicident.
Severe headaches, nausea, dizziness, joints hurt, muscles feel weak, swollen lymph nodes in throat, hard to breathe, extreme fatigue, gastrointestinal problems, shaking, anxiety, afraid to sleep.
I was pregnant when I received my flu shot from work. Had no issue when I would get my check ups. Then I had my flu shot the end of September. That's when my baby stopped growing normally. She was delivered early the next month. She was only 3 lbs 14 oz on Oct 27 2016. She was my first pregnancy.
Got completely better from all pre-existing illnessess; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 71-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "crest syndrome" (unspecified if ongoing), notes: She has connective tissue disease crest syndrome; "fybromyalgia" (unspecified if ongoing), notes: She no longer has fybromyalgia. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for covid-19 immunisation, reaction(s): "sick". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Got completely better from all pre-existing illnessess".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541072 same patient/drug, different dose/events.
I had a 3 inch rash on my back that was red, and warm and painful when touched.  I went to I was diagnosed with cellulitis and prescribed Bactrim for 7 days.  The rash continued to increase in size and began to itch, so I saw my primary care physician, on 7/20/21.  I was then diagnosed with a fungal rash and was told to stop taking the Bactrim and begin using  terbinafine 1 % cream topically 2 times daily and hydrocortisone as needed for the itch.  The rash has lightened and is less itchy as of today, 7/24/21.     I received the V-Safe questionaire texted to me on 7/16 and answered that I saw a doctor for my rash.
Couldn't move. Was stiff and still is painful and swollen. Bumps broke out. *Follow-up report on 2/20/03: Severe pain, stiffness, rash, bleeding muscle, inside arm soreness.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was given the PFIZER COVID SHOT (1st Shot)... The patient was informed to seat for 15 minutes after the shot. Unfortunately, he arised from his seat accidently prior to the 15 mins and fell down.. He had a dizzy spell.. He is currently being monitored by EMT and the emergency room. Prior to leaving the pharmacy he was doing much better and responsive.
Information has been received from a physician and the office manager concerning a 61 day old male patient who on 01-APR-2009, was vaccination with PNEUMOVAX 23 (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX 23 (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
raised, red, itchy welts covering an area approx 2 inches wide by 3inches high extending from injection site down side of arm
Scalp psoriasis that got worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Scalp psoriasis that got worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis of scalp.    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 PSORIASIS (Scalp psoriasis that got worse). At the time of the report, PSORIASIS (Scalp psoriasis that got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced event after either the Pfizer or Moderna Covid-19 Vaccine.  No concomitant medication details was provided.  No treatment medication details was provided.
8 days later presents to our ER with decreased energy, fatigue, lethargy, delirium, and shortness of breath with several falls over the past few days.  SOB increasing over the last few days and found to be in respiratory distress this morning. 4/28/2021.
This spontaneous report was received from a pharmacist referring to an approximately 72 year old female patient. No information was provided regarding the patient's concurrent conditions or concomitant medications. The patient was not sure whether she received a dose of ZOSTAVAX while previously living in a nursing home. The patient stated that she had received "vaccines" on unspecified dates. However, the pharmacist stated that there was no history of vaccines in the patient's records. On 20-JUN-2017, the pharmacist administered a dose of PNEUMOVAX23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient also received ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was filed.
I was in for a CT SCAN at my Oncologist and the CT scan revealed I had cloudiness in my lungs. The DR seemed considered and read the results with a specialist and called me to confirm that I had contracted pneumonia. And I've been dealing with pneumonia for the past 2 weeks. Wheezing and shortness of breath and I've never had pneumonia a moment in my life. Never even came close. They scheduled a followup CT scan in 3 months.
Itchy welts at the injection site/Red raised patches around injection site. Blotchy rash.
Myalgias, low grade temp, chills. Advil and Tylenol as of 6/27.
headaches; a bit of 'a punky feeling'; the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple; affecting his hearing; When he presses on it he feels pressure on his ear/The right side was not as much; This is spontaneous report from a contactable consumer (patient). A male patient of an unknown age (Age: 61, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Feb2021 at 16:00 as DOSE 2, SINGLE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unknown date dose 1, single for Covid-19 immunisation. It was reported that, patient received the second dose of the covid vaccine on 09Feb2021 at 4:00 PM (PST) and as the day progressed patient had headaches, a bit of 'a punky feeling', and the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple, affecting his hearing. When patient presses on it he feels pressure on his ear. The right side was not as much. The outcome of the events was unknown.  Information on Lot /Batch Number has been requested. Follow-up attempts are completed.
About 24 hours after shot I developed a fever - 101.5.   Two weeks after the shot I developed some intermittent swelling in my calves, ankles and feet, some days more than others.  It continued for several weeks- it may not be over yet.
At about 8 PM on the day of the first vaccine I became dizzy And required assistance to walk.  I would collapse to ground and could not get up if no one was around.  Exhausted and confusion..
2-3-21 headache and nausea 11pm duration around 2 hours, not sure because I didn't check the clock. 2-4-21 light case of hives after drinking coffee at 6am, stopped coffee better in about 30 min. 2-7-21 hives after drinking coffee, stopped coffedd, longer duration, took benedryl and the redness left after an hour, itchiness remained for another hour or so.
Received injection on 6/29/16. On 7/1/16 at approx 1:30pm received a phone call from patient saying she was having numbness and twitching of fingers in right arm and hand. (Inj in Left arm). Said she was having difficulty speaking and her co-worker had called an ambulance.
Onset of severe sacroiliac pain and tenderness, gluteal pain making ambulation difficult.
Breakthrough case admission after 2 vaccines Pfizer 4/2/21 lot# EW0172;  Pfizer 5/13/21 lot# ER2613
pain in left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number l32mf, expiry date 31-MAY-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain in left arm). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023 Reporter was the patient, who received her first dose of Shingrix on Monday.  She stated that after receiving the dose, she experienced pain in her left arm.  She had tried ice, Tylenol, and Advil for the pain.  The pain was not as bad on day of reporting but had not yet resolved. The reporter consented to follow up.
In first two days following second dose of Pfizer vaccine, patient had "normal" side effects of fatigue, low grade fever, chills, etc.    On evening of day 3 patient developed headache, nausea, and severe chest pain.  Emergency Room visit showed normal EKG an X-Ray but bloodowork showed troponin levels of 18,300 at 10:30 pm and 19,905 overnight.  Patient was diagnosed with myocarditis and admitted to pediatric ICU at Hospital.
Donor received a hepatitis B immunization on 10/13/2022. Donor reported that the next day, 10/14/22, at approximately 10am, she was experiencing significant pain in the entire left arm.  This pain was made worse with any slight movement of that arm, laying on that arm or on that side, and just touching anywhere iat the left upper arm area. Donor also complained of itching and a small lump at the site of puncture.  A subcutaneous small mump was noted at the site which sized approximately 0.5cm x 0.5cm and was non-tender. These symptoms persisted for approximatelly 3 days, before subsiding spontaneously. Donor denied experiencing any other symptoms or complications.
r arm is in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (r arm is in pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (r arm is in pain). At the time of the report, PAIN IN EXTREMITY (r arm is in pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment information were reported.
Left thigh edematous, red and hot to touch. Injection site skin, purple in color.
Experienced nausea, excessive vomiting, HA and worsening of insomnia a week after vacc. In mid May, primary MD prescribed AMBIEN then later trazadone and assessed that vacc is culprit since there was no other change in medical profile. In June, severe dizziness and painful HA radiating from head to neck. Internist assessed vacc is cause of symptoms.
approx 10hr p/vax pt had pink in diaper, went to ER did UA & was + for blood dx w/UTI tx w/septra x 10 days;pt had been on augmentin for ear infect w/last dose of med taken on 18FEB98 AM;
Information has been received from a physician concerning a 2-month-old patient who was vaccinated by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that the patient subsequently began to vomit within six hours of being vaccinated.  Unspecified medical attention was sought.  The vomiting continued for a period of 24 hours and then resolved.  Additional information has been requested.