chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received the 1st dose of Pfizer COVID-19 vaccine on 4/8/21. Prior to administration, pt reported to vaccinator that she has a hx of allergic reactions (no anaphylaxis) and sees an allergist. Pt reports that her allergist has her come to the Allergy Clinic for the flu vaccines and to be monitored.   Vaccinator escorted pt to check-out and reported to me that pt should remain for 30 minutes of observation d/t reported hx.   Pt sat in observation for about 10 minutes and began to feel very warm.   Volunteer from Observation group alerted RN who was volunteering as a vaccinator.   Staff notified me and I joined in the recovery room with the pt.   Pt appeared very flushed and we observed redness and some red bumps on her face and neck, Pt chest appeared red, as well.   Hx of allergies to shellfish, cats, seasonal and others yet unidentified.   Applied cool cloth to back of neck, and gave juice and crackers.   Vitals:  12:10pm-- P-98, BP-120/88, O2-98% on RA  12:25pm--P-98, BP-131/91, O2-98% on RA  Due to slight increase in BP and not seeing resolution to the flushing, it was determined to give Benadryl.   25 Mg Benadryl, PO @ 12:30pm  Vitals @ 12:45pm:  P-84, BP-91/56, O2-99% on RA  Flushing resolved and pt reported she felt well enough to go home.   Discussed plan to get to urgent care STAT is she experienced worsening symptoms, especially difficulty swallowing and/or facial swelling.   Pt informed that a VAERS report would be filed and she may be contacted by this agency as they collect data on immunization reactions. Pt is agreeable.   Compass-Safety report will also be filed.
Persistent, significant joint pain; most significantly in Right hip and left shoulder.  Motrin as needed for pain, now nightly.  Appointment scheduled for PCP today.  Joint pain not present prior to vaccine.  Exercise routine involves cycling and walking 4-5 days per week.  Cannot walk without gait disturbance due to pain, especially in right hip.  Cycling cadence mostly preserved, however right hip range of motion needed  to mount and dismount bicycle is significantly reduced and painful, making starting and stopping difficult without stumbling or falling.
Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, and within 15 seconds reported a ?warmth? or ?burning? sensation in L arm, axilla, shoulder, chest, and stomach, and an almost immediate ?metallic taste? in her mouth. Shortly after she felt an increase in her heart rate. Approximately 30 minutes later she says she experienced nausea and like her ?tongue was swelling.? She went home and took a Benadryl and all symptoms had resolved within 30min-1hour. The following day (4-7-21), she was ?achey? and had low grade fever (Tmax 100.5F reported). That night (4-7-21), she felt like her axillary region was slightly sore or starting to swell, but woke up 4-8-21 to severe swelling, warmth , visible bruising,  pain, tenderness, all in the L axillary region, so sought care at our office. She did have visible and palpable swelling under the L axilla, and it appeared her vaccine was given in the proper location and there was no local induration/warmth/tenderness at the injection site.  She felt the same on 4-9-21, and by 4-12-21 all the axillary symptom had resolved and she only had sore lymph nodes under her jaw. By 4-14-21 all symptoms had resolved other than one small slightly tender lymph node under her jaw.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a adult female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201545, reported by the same reporter.
Painful, swollen lymph node in  left axilla, same side as injection site; Painful, swollen lymph node in  left axilla, same side as injection site; This is a spontaneous report from a contactable healthcare professional (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ek5730), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol, cyclobenzaprine hydrochloride (FLEXERIL), ibuprofen (ADVIL), paracetamol (TYLENOL), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced painful, swollen lymph node in left axilla, same side as injection site. No treatment was given for these events. The clinical outcome of painful, swollen lymph node in left axilla, same side as injection site was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt given Prevnar injection into upper let thigh 06/06/02. Mother states pt has red raised lump in area of injection site on 06/07/02 was seen in office for follow-up by doctor.
Patient received a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 19-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA006219: US-009507513-2103USA006220: US-009507513-2103USA006222: US-009507513-2103USA006223: US-009507513-2103USA006224: US-009507513-2103USA006218: US-009507513-2103USA006217: US-009507513-2103USA006216: US-009507513-2103USA006215: US-009507513-2103USA006221:
Hospitalized (10.1.21);  COVID-19 positive (9.30.21);  fully vaccinated   Admission Date: 10/1/2021 Discharge Date:  10/03/2021 PRESENTING PROBLEM: Acute respiratory failure with hypoxia  Acute hypoxemic respiratory failure due to COVID-19 COVID   HOSPITAL COURSE: 77-year-old male presented to Hospital with increased shortness of breath.  He was recently on a trip when the person ahead of him in the above was noted to be ill.  He began developing symptoms after returning home from the bus trip with cough fever shortness of breath.  On the day prior to admission he had been started on oral Decadron.  Upon admission he was found to be COVID positive and admitted for treatment of hypoxemia.  He was continued on IV dexamethasone and remdesivir.  He generally felt well but did have continued oxygen requirements.  He was set up for home oxygen therapy prior to discharge.  He is to complete 10 days of dexamethasone post discharge.  At the time of discharge he should utilize 1-2 L of oxygen at rest and increased to 5 L with activity.  It is hoped that over the next week he can wean off to no subsequent oxygen.
administered with an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Within a few hours I got a spontaneous black eye (right side) upper lid - very dark bruise (looks like it will last a few weeks)  Following day I had severe aches and exhaustion  By second day still exhausted
Hives around mouth, on neck and moving down back itchy face. Mom gave Benadryl 25mg.
Injection caused severe shoulder discomfort believed to be related to placement of the vaccination. Vaccinator gave the injection too high missing the deltoid.
Pain and swelling in the left axilla, worsening 2 days after vaccination. Heaviness of left arm+
Information has been received from a physician concerning a 70 year old male patient who "recently" in approximately May 2007 was vaccinated SC with 0.65 ml dose of Zostavax. It was reported that in approximately May 2007, the patient developed a rash "in his groin area". The physician is not sure if the rash is from the vaccine or not. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Stated on 1/27/21 she had 3 "bumps" on  her right shoulder.  The bumps gradually multiplied and moved down arm to wrist. She stated there are approximately 20 bumps ( some are in 2 "welted areas" or groups of 4 or 5). She stated the "bumps or welts" now are painful and some are "crusted". She stated she has pain and "burning"  in underarm area and bra-line under her breast, although there are no bumps in that area.  She states the pain is not improving.  She stated that the nurse at her physician's office told her to call the Health dept to report it, but they have not seen her yet.  I  told her I would do the report but recommended  she evaluated by her PCP due to not improving.
(R) arm became swollen, slightly red, painful with difficulty using arm. Experienced chills, malaise.
Headaches, chills, tired, no energy, low-grade fever (that has never went away), my eyes hurt and my nose is stuffy. I went to get a COVID test but it was negative.
Report 20010119991 described erectile dysfunction in a 41 year old male who received hep B vaccine (Engerix-B). The patient was allergic to penicillin. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Engerix-B and hep A vaccine (Havrix). The vaccinating physician reported that the pt experienced chills and "did not feel well" the evening of 04/25/2001. Three days after on 04/28/2001, the pt reported general achiness, numbness and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, rash, and a small perioral ulcer. viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C-reactive protein were performed. (results of all evaluations performed were not provided). The physician prescribed acyclover and referred the pt to an infectious disease specialist. On 05/16/2001, the pt's fathe rreported that his son developed a generalized, red, raised rash; itching; flushed face; nausea; fever; and mouth blisters within four hours of immunization on 04/25/2001. "Several days later," the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and "possible nerve damage" (NOS). The urologist reportedly prescribed phenazopyridine 200mg and levofloxacin (Levaquin). On 05/18/2001, the pt's father reported that his son's "condition has worsened." He stated that his son had "sexual dysfunction due to numbness in his penis." He also reported that the pt's facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt "now will suffer with a loss of income, too."  On 05/18/2001, the pt stated, "I'm having a reaction to one or both of your vaccines. I'm having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face,"vague malaise," a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved, and the pt's condition had "worsened," per the pt's father. On 05/31/2001, the internist found the condition of the pt to be "normal" other than the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak; the pt subsequently felt better "for awhile." When he stopped taking Medrol DosePak, his symptoms returned
Hives; Itchy arm; Rash; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE RASH (Rash), VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE PAIN (soreness at the site of injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of injection). On 11-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash). On 12-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE RASH (Rash), VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE PAIN (soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
8 days after the shot, while showering, I noticed my arm was itchy at the injection site. I then felt it and noticed a raised, red, and very warm bump that grew throughout the day and continued to grow the following day. On the third day after discovery, the bump and redness went away and now I feel a dull achy pain at the injection site.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 13-JAN-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left axillary lymphadenopathy and pain at onset 10/6/21, gradually improving and no longer painful.
I got the moderna 2nd shot last friday and im starting to feel more side effects now (5 days after getting the shot) is this normal?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I got the moderna 2nd shot last friday and im starting to feel more side effects now (5 days after getting the shot) is this normal?) 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 was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I got the moderna 2nd shot last friday and im starting to feel more side effects now (5 days after getting the shot) is this normal?). At the time of the report, VACCINATION COMPLICATION (I got the moderna 2nd shot last friday and im starting to feel more side effects now (5 days after getting the shot) is this normal?) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   Reporter did not allow further contact
My right arm I could not lift it, I had a temp of 103.3 for three days, I ached all over. I was just totally exhausted for about two to three weeks.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Severe Headache 18 hours post injection. Headache lasted approximately 14 hours with little relief from OTC Tylenol.  Injection site became extremely painful 8-10 hours post. This lasted approximately 24 hours.  I did not seek medical attention for either of these side effects, and both side effects were just about gone the morning of April 10.
9/1/2021- Pt c/o slight headache before vaccine, was recommended to wait if not feeling well patient consented to receive the vaccine. Patient was monitored for 15 minutes. After the 15 minutes were up patient stated she was feeling dizzy and  with nausea. A/O to time, date, and location, vitals were taken at 2:15pm read BP-127/84, HR-84, RR-23, O2 Sat-98% she was provided a barf bag, she proceeded to vomit. she stated feeling a bit better after, she stated having history of migraines and Anemia. Pt stated feeling these symptoms before with migraine headaches. Provider was called to check on her as she was still not feeling well, stated she should just be monitored and if symptoms worsen to be sent to hospital. Provider requested RBS to be taken read- 149. Vitals taken again @ 2:30pm BP-119/78, HR-81, RR-24, O2 Sat-98%. Pt was monitored until she was feeling better, she laid down for a few minutes, ice pack was provided to her. . Pt was provided water and laid down again for few minutes with legs elevated. Pt stated she was feeling better and was ready to go home. Pt called daughter as she was advised to not drive herself. last vitals read BP-119/72, HR-72, RR-24, O2 sat 98%. Pt was walked out to her daughter's car with assistance to daughter alert and oriented at all times.
On day 12 after first dose itching began. On day 13  a raised, red 2.5-inch circle around the injection site appeared and the itching became severe. Hydrocortisone Ointment (2.5%) was applied, but afforded little relief. The rash and itching continued for about three weeks, only lessening the last  several days.  Also on day 12 after the first dose, my lower lip began to feel as if it were sunburned (which it was not) and swelled slightly. Lip balm was applied. The strong burning feeling lasted burning lasted for about three weeks, only lessening the last  several days.  On the day following the second dose, a smaller red circle appeared around the injection site which itched moderately. It did not continue to itch or appear red after 3 days post injection.
lack of drug effect; diarrhea; fever; This spontaneous report was received from a consumer, concerning a 4-year-old patient of unknown gender. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 23-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once in the left thigh by subcutaneous route (lot number, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 29-MAR-2023) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1863317 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Lot number 1863317 does not match any Company product as confirmed by Lot Verification team. The vaccines were administered as prophylaxis.  On an unknown date, the patient experienced mild fever (pyrexia), diarrhea and lack of drug effect.  At the time of the report, the outcome of the events was unknown.   The causal relationship between events and the suspect vaccines was related, further described as "expected side effects of given vaccines".  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA003956:
Patient experienced loss of appetite, low fever, headache, shivers/chills, and generalized fatigue starting Sunday 2/7/21 lasting through Tuesday morning 7/9/21. Patient's family member reported the patient experienced general flu like symptoms for a couple days. I called patient 02/10/21 and patient was feeling like his old self again.
Case number PHEH2015US016933, is an initial spontaneous report from a nurse received on 27 Aug 2015. This report refers to a 32-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157403, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 27 Aug 2015. It was reported that patient received FLUVIRIN PFS that had a temperature excursion of 10.49 degrees Celsius for up to 25 minutes. No adverse event was reported due to the maladministration.