chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exposed to temperatures below 32 degrees F.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192698 and 2019SA192700.  This case involves a 13 years old male patient who received 0.5 ml dose of vaccine IPV (VERO) lot PIA461M (Expiry date 03-May-2020) and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot no U6101AA (Expiry date 23-Oct-2020)  via intramuscular route in unknown administration site on 28-Jun-2019.  It was an actual medication error due to incorrect product storage.   It was reported that received vaccines that were previously exposed to temperatures below 32 degrees Fahrenheit.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I began having significant muscle soreness into my neck and distal to site into left arm. Symptoms are unilateral on left. The muscle soreness limited my ability to drink from a glass, requiring resting neck due to fatigue, limiting cervical ROM with extension and left rotation. I have been taking Ibuprofen for pain, heat/ice at night when worst. Symptoms at injection site have diminished.
Dizziness, Arthralgia, NauseaVomiting, "Shaky" Narrative: Vital Signs were assessed at 0905: T97.8 P77 RR14 B/P 137/73 and Pulse Ox 94%. Then, employee stated at 1000 "He feels tired with body aches and no nausea" Vitals Signs were T97.5 P63 RR16 B/P 124/74 and Pulse Ox 96%.
Pt complained  of L arm numbness from injection site down to L pinkie. Saw FMD and was given anti-inflammatory meds after better, next day, numbness sore. No office notes attached.
Tightness in my chest; Every time I am walking around or doing anything I am quite winded and then I need to sit down, just to catch my breath; This is a spontaneous report from a contactable consumer, (the patient, reported for self). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8733), via an unspecified route of administration on 28Mar2021 11:00 (at the age of 34-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patent received any other vaccine in four weeks and other medications in two weeks. It was unknown if patient had COVID prior to vaccination. Patient stated that he had vaccine shot 2 days ago and today he had tightness in the chest. Every time patient walked around or did anything he quite winded and then need to sit down, just to catch breath through. The patient did not receive any treatment for the events. It was unknown if patient had tested for COVID post vaccination. The outcome of the events was unknown.  No follow-up attempts were needed.
patient stated he was  feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every  10minutes patient later after third  set of vitals stated he was feeling back to normal patient  was escorted  back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18  o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.
48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortness of breath. chest x ray showed RUL consolidation. when patient wosened over the next 48 hours from respiratory standpoint including new oxygen requirement and hypotension, decision was made to perform chest ct which confirmed presence of RUL pneumonia. the following day, the patient was bronched and the resultant bronchial alveolar lavage that was performed has thus far been completely negative. repeat chest xray four days later showed resolution of RUL consolidation and patient was no longer symptomatic.
This spontaneous report was received from a physician, referring to a 4 month old male patient. The patient did not have relevant medical history, concurrent conditions or concomitant medications. On 05-JAN-2018, the patient received a dose of improperly stored ROTATEQ, orally for prophylaxis, lot # M043836 and expiration date on 17-JUN-2018. On 22-JAN-2018, the patient experienced fever and runny nose and went to the emergency room. The patient was not admitted to the hospital and it was unknown by the reporter if treatment was given for the events. The physician reported that the vaccine experienced temperatures below 32 F for 9 hours 6 minutes and of 32 F up to 35 F for 19 hours 11 muntes. There were no previous temperature excursions reported and the call was because of a data logger. The outcome of fever and runny nose was not reported. The physician considered that the events were not related to the vaccination with ROTATEQ.
Approximately 16 hours of having the vaccine, I started to have cold chills.  I slept for most part of the day and was running a temperature of 102. Had muscle aches all over Especially in my knees.   It?s been 48 hours since and I am starting to feel a lot better
Six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for her 14-year-old daughter and six female patients. This report is about six female patients.  Six female patients of unspecified ages received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single, for COVID-19 immunization. The patients' medical history and concomitant medications were not reported. On an unspecified date, six of the patients developed shingles within several days of receiving the vaccine. The clinical outcome of the event was unknown.
Pt. in office on 12/9/2011 for HPV #2, then mention that she had neck pain, leg cramp on left side the next day or two after getting HPV. She question if that was a s/s of reaction. No treatment was done.
Severe headache 2days after vaccine, then nausea and vomiting with dizziness 3 days after vaccine
Approx 24 hrs post inject devel inc temp (102-104) & swelling to lt thigh where inject given-red & warm; swelling & erythema were 3x3inches;
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VAQTA 50/1.0 U/ml (lot # M002268, expiry date 20-SEP-2017, dose, dose number, vaccination site unspecified) intramuscular route. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Admitted to hospital on date of adverse event for treatment of COVID-19 positive following completion of COVID-19 vaccine series.
The patient was due for the second dose of the Pfizer primary series for age groups 6 months - 4 years-old, but staff member assigned to patient administered the Pfizer bivalent dose instead of the primary series. The provider was notified, patient did not experience any symptoms, and was administered the bivalent dose as the second vaccine versus the primary series. No symptoms or other side effects noted.
"Was sick"; "slept all day Tuesday"; Teeth sensitivity/can barley eat or drink due to the teeth sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity), ILLNESS ("Was sick") and HYPERSOMNIA ("slept all day Tuesday") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399W and 036AZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity) and HYPERSOMNIA ("slept all day Tuesday"). On an unknown date, the patient experienced ILLNESS ("Was sick"). The patient was treated with SODIUM FLUORIDE (SENSODYNE [SODIUM FLUORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity), ILLNESS ("Was sick") and HYPERSOMNIA ("slept all day Tuesday") outcome was unknown.      No concomitant medications were mentioned. Batch number of 2nd dose "028A 2 or Z IA". This case concerns a 65-year-old, male patient with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of hypersomnia with other non serious unexpected events. The event of hypersomnia occurred approximately 2 days after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 65-year-old, male patient with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of hypersomnia with other non serious unexpected events. The event of hypersomnia occurred approximately 2 days after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Stomach pain 2 days post vaccination. When eating, feels nauseous and may vomit.
My arm is very, very sore now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is very, very sore now) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION SITE PAIN (My arm is very, very sore now). At the time of the report, VACCINATION SITE PAIN (My arm is very, very sore now) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Sore right arm, increased stiffness in neck and shoulders, intermittent headache, right hand tingling (thumbs and fingers) and slight swelling of thumb and last 2 fingers on right hand, right thumb pain at base, right side stomach pain moving to just below center rib cage, left thumb pain at base, pain over left eye, fatigue, sneezing, dry eyes, swelling of left and right arm pit lymph nodes, fever in the evening of 6/1 and 6/2, sinus congestion, off and on sharp cramping in right knee the evening of 6/1, two lumps on right arm above elbow by 6/2 morning (became rashy, swollen and hot/itchy, looked like sunburn), left breast tenderness, back and leg aches. noticed muscle twitch above right elbow on 6/4. Took
pt recv vax 28APR97 & on 1MAY97 pt devel 3-4 vesicles;
sacroiliitis; pain in her thigh; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient was due for her 2nd dose and wanted to know if she can take the vaccine. She was diagnosed with sacroiliitis by her doctor upon her X-Ray. She did not experience any side effects after the first dose but had pain in her thigh. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient stated that the night of the injection he started feeling pain at injection site.  He was consulted on the possible side effects , but didn't expect it to last almost a month.  He sometimes has problems moving his left arm .  Pt did not take any NSAIDS nor use  ice packs.
Leg has been red; Leg has been itchy; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Leg has been red) and PRURITUS (Leg has been itchy) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALSARTAN, METOPROLOL, OMEPRAZOLE, ATORVASTATIN, TAMSULOSIN, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 10/90), BRIMONIDINE TARTRATE, BRINZOLAMIDE (SIMBRINZA), LATANOPROST, EMPAGLIFLOZIN (JARDIANCE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and IRON for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Leg has been red) and PRURITUS (Leg has been itchy). At the time of the report, ERYTHEMA (Leg has been red) and PRURITUS (Leg has been itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Received 4 month immunizations on 04/13/04.  Developed cold symptoms 09/14 and fever to 101.3.  Pt was seen in office 16:00 on 09/16/04.  Diagnosed with upper respiratory infection and otitis and treated with Tylenol and Amoxicillin.  Parents reported increased nasal congestion not latching to breast feed. Called advice nurse 5:00am 09/17/04 with questions regarding cold and fever (100.8). Then at 8:00am mom was holding baby; noticed no heartbeat.  911 called pt in asystole from initial paramedic contact until pronounced at hospital. PCP states patient's mother mentioned the baby was sleepy and quieter than usual after her immunizations.  Nurse follow up on 10/05/04 states: "Sleeping poorly, coughing, and fussy, gagging."  - 10/05/2004 Review of well-baby progress note from 9/13/04 indicates child essentially normal. The ill-baby progress note indicates fever, runny nose/worsening congestion, fussiness, difficulty eating, gagging, cough, and not sleeping well. There was no diarrhea or vomiting. Exam indicated erythematous and bulging right TM with normal left TM, clear rhinorrhea, and clear lungs. - 10/28/2004 ER report indicates discharge impression was cardiopulmonary arrest. Baby arrived to ER with CPR and ventilatory assistance in progress. At no time was there a spontaneous pulse or respiration. Several doses of epinephrine were administered. Baby's body was released to the morgue as a coroner's case.  - 03/15/2005 autopsy report states COD was acute bronchopneumonia.
shingles on the inside of his legs; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shingles during the time period he was waiting to get his second Shingrix, on the inside of his legs, and it was so painful that he had to go to the emergency room twice.
administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported  No treatment information provided by the reporter
Extreme sore arm at injection sight. Headache. Joint ache (both ankles). Extreme fatigue.  All symptoms began 4 hours after receiving injection.  All symptoms subsided within 24hrs after side effects began.  No treatment required.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions.On an unknown date, the patient experienced herpes zoster, for which was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Additional information has been requested.
Case number PHEH2014US025145, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 69 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
She got her vaccine at 9am; at about 2:30pm, she went outside to play and I noticed she had hives on her chest, sides, and back. I took her to urgent care worried whether it was a reaction to the vaccine. The doctor couldn't completely diagnose whether it was caused from the vaccine, but informed me to give her Benadryl to see if it'll subside her reaction. He also told me to follow-up with an immunologist before receiving second dose to confirm whether it was vaccine-related. on the way home, bought Benadryl and gave it to her right before bed at 6:15pm. When she woke up the next morning, the hives went away at night, and she was fine.
I developed a bitter taste; I am not able to eat; I felt so bad; I started coughing; I feel so sick and helpless; This is a spontaneous report from a contactable consumer (the patient), a front line worker.  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/Lot number unknown, via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Dec2020, a moment after vaccination, the patient experienced a bitter taste, was not able to eat, felt so bad, started coughing, felt so sick and helpless. The events were non-serious with outcome of unknown.  The information on the batch/lot number has been requested.
I woke up on March 28th with welts, redness, and swelling around my eyes, by the end of the day I noticed scattered hives on my arm and stomach, I took a Benadryl and went to sleep. The next morning, March 29th, I woke up with my whole face and eyes covered in hives and swollen. My arms, legs, stomach, and back all had severe hives and rashes. I went to urgent care promptly where I was given a 40mg Solumedrol IM injection in my right arm, and I was prescribed Cetirizine 10mg, Famotidine 20mg, and prednisone 20mg for 5 days. After taking those medications my hives went away that day but started to come back less than 24 hours after taking the prescriptions. The next more I woke up again with hives on my face, arms, and chest. I took my medication and the hives went away until about 5pm the same day. This morning 4/1 I woke up at 1am with a red rash and hives all over my legs, arms, and face, but this time my face and my hands were swollen, which didn't happen previously. The hives seem to be getting worse, and the medication are not lasting long enough to keep them under control. I called the urgent care Dr. and she told me to take 40mg Prednisone daily for 5 more days. I also made an appointment with a PCP for Monday 4/1.
Osteoarthritis flare up in  left foot and left knee which has persisted and worsened.  Not a previous condition.
C/o of dizziness and tunnel vision right after receiving vaccine. Able to move to the bed on own. Initial BP 116/70, HR 66, O2 sat 99%. Does have history of HIV infection for which she take PO meds "for a long time". Vital signs remained stable throughout her stay. Able to dangle and ambulate without dizziness. Drinking water. Symptoms resolved on their own. Discharged feeling much improved.