chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 days after vaccination - spots on lower right leg further developed a larger area on same leg; Left leg has 1 spot on ankle and lower leg and groin and 2 on inner thigh pt saw MD on 11/15 - Diagnosed with Zoster -given FAMVIR 500mg tid x 7D - No pain - occasional itchiness.
Cold; Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion). At the time of the report, FEELING COLD (Cold), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24 May 2021 included patient demographics.
Erythematous rashes over upper extremities - sites of injections.  BENADRYL 25 mg every 6 hrs.
Pt. reported to ER with febrile seizures 8 days after administration of MMRV (PROQUAD).
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:10, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, injection site pain. On 12 November 2008 at 10:20, the subject experienced dizziness, and panic sensation. The subject was treated with Epinephrine. On 12 November 2008 at 11:20, the subject experienced trouble breathing and throat tightness. The healthcare professional reported the subject received FLULAVAL at a flu vaccine clinic held at a job site at 10:10 and immediately experienced swelling, redness, and pain at the injection site. The subject was monitored for five to ten minutes and then felt panicked and dizzy. The subject then received epinephrine 0.5mL, felt better and went back to work. One hour later the subject returned complaining that she was having trouble breathing and her throat was tightening. She was then given a second dose of epinephrine (0.3mL). She did not respond to the epinephrine so she was given another 0.3mL dose. The subject did respond and stated she felt fine. She was advised to go to the emergency room, but the subject felt she did not need to and she therefore, did not go to the ER. The reporter stated these adverse events resolved between 12-12:30 pm. The healthcare professional considered the events were clinically significant (or requiring intervention). On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
injection site swelling; Ryanoid phenomenon (cold hands); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's disease.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)). At the time of the report, INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Pt was only Due for DTaP-IPV, this is what was ordered. Wrong vaccine given. Pt has had no adverse reaction to the extra dose of Hep B.
Low grade fever, weakness, nausea, mild diarrhea. Increased glucose reading had passed kidney stone & felt mildly ill the day prior to injection. Felt worse after inj after 3 days symptoms not as severe.
Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to feel faint and dizzy. She also reported feeling nausea. Patient was alter and oriented, no difficulty breathing. Vitals were taken, patient's O2 was 98, pulse 56, and BP 90 by palpitation. Second BP taken 5 minutes later, BP raised to 118 by palpitation. Patient sipped on water, was laid back in the car, and windows rolled down. Patient reported she mitral valve prolapse and when she gets anxious, she starts to feel faint. Patient continued to be alert and oriented and within 15 minutes after first feeling faint, she stated she was feeling better. Was able to walk from driver to the passenger side of the car, patient reported she felt better and vitals were normal.
Bright red rash, swelling, and pain from elbow to top of shoulder.  Lump near shoulder blade (enlarged lymph node).
c/o pain in rt knee joint & behind the rt knee; lasted 3hrs; pt cried entire time nothing relieved it, & it happened 3AUG95 @ 230AM; called MD & 1-800; pt taken to MD 3AUG95 3PM;
This rash is clearly distinct from the hand-foot-and-mouth rash that he had prior and mother sent pictures into chart.  The timing and characteristic of this rash appears consistent with an MMR vaccination rash which occurs in up to 5% of individuals after this injection. Another possibility that we discussed was heat rash which is the next item on the differential.  Mother was reassured in either case.  Plan on treat symptomatically with calamine lotion.  Return to clinic if symptoms persist or worsen
Burning sensation immediately. Arm swollen, bright red, hot for a full week. Arm still purple at injection site after two weeks.
Client received Moderna second dose vaccine at 2:10 pm. Stated no problems with first dose. Had a history of numerous allergies including anaphylaxis to mold but no injectables.  instructed to wait 30 minutes.  After about 10 minutes, client complained of trouble breathing, dizzy and itchy mouth. Nurses noted extreme trouble breathing . EPI 0.5 ml given SQ in left leg. Blood pressure 189/90, P 138 02 sat 99%. No wheezing noted. Skin clammy. 911 called. BP better at 130/82 P 110 and 02 sat 100%. Clients breathing improved. Cool compress applied to head and elevated legs. Client was alert.  EMS arrived at 2:35 pm and transported client to ER.
I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my appointment got cx?d due to our weather. So it got rescheduled to Thursday 2/18 at 12p.   My 1st dose was Moderna. I gave the lady my card and a Moderna sticker is clearly on it and readable. She came back to my vehicle and gave my 2nd injection; apparently she gave me Pfizer (I didn?t know that until she handed my card back to me). She handed my card back; I looked down at it and saw it said Pfizer. I said, ?What just happened? I got Moderna the 1st time why does my 2nd one say Pfizer?? She didn?t have anything to say. She then left immediately to go get someone else to talk to me. This person said I wasn?t the 1st person this has happened to. It still has the same mRNA molecules in both vaccines. She also said I shouldn?t need another dose of any vaccine. I should be okay even though I got the different vaccine. I was also told by her that when the sites run out of Moderna or Pfizer; then they are giving (employees and the public) the opposite one that they have on hand. (I don?t know how true this is but this is what I was told).    After this happened I contacted my Director and my Manager and informed them of what happened. They both said I did nothing wrong Director contacted our Employee Health office. Then the Employee Health Nurse called me to check on me and get some information.    Nurse called me again on Friday to see how I was and to take more information to fill out an incident report. Then she was going to talk to the Head Pharmacist again and get back to me about what he said. I haven?t heard back from her yet.    I?m still upset because that incident should never have happened (and it?s bad that it happened to an employee). Our employees need to slow down. They need to make sure their name badge is visible (the lady giving mine- I never saw her badge). Then they need to verify what vaccine they have in their hand with the pt/person again before they inject it to avoid another situation from occurring like mine).    What I?m more upset about is: there is no research as far as what having 1 dose of Moderna and 1 dose of Pfizer is going to do to my body?? Am I protected at all? Am I more protected? Will I have bad side effects later? We don?t know. That?s the scary part.   I just don?t want this to happen to another employee or anyone else.   So far the only thing I had happen to me since the injection is a painful sore left arm. I have no idea what effects I may have later...??.... from having Moderna in my system; then Pfizer.
No adverse event. Mixed dose series. Patient had received J & J Covid Vaccine on 3/6/21.
Pt was weak, diaphoretic, lightheaded, loss of hearing, blurred vision.  RN had pt lay on the floor, BP 120/88, Pulse 88. RN gave pt 0.5mL of Epinephrine and called 911. at 1400. Pt BP 128/60 and oulse 90 at 1410. Paramedics arrived at 1415.
Fever, chills, weakness, feeling faint, non-radiating sub-sternal chest tightness. Onset 12-13 hours post vaccine, lasting 1 -2 hours.
body ache; bad headache; dizziness; This is a spontaneous report from a contactable consumer (patient's father). A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: Not reported), via an unspecified route of administration on 14May2021 around 17:00 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech Covid 19 vaccine on 14May2021 around 5pm and she has got some really bad symptoms right now and don't know what to do. On 15May2021, the following morning she had a bad headache and some dizziness. On an unspecified date, the patient had body ache. The patient received treatment for event bad headache and dizziness with little naproxen. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Approximately 4" x 6"  area of skin on my right side a little above my waist feels as if I have  a burning rash, or a very wide scrape.  The vaccination site itself is clear and normal.  It began a few hours after the injection, it is constant,  and it persists to the present.  There is nothing visible.  On a pain scale of 1-10, it is noticeable but less than 1 unless I take a deep sudden breath and stretch this area, when it rises to a solid 1.  I have not yet discussed it with the doctor because it seems so minor, but if it continues another week I will see the doctor.  I expect to take the next vaccination on 4-33-2021 unless he advises otherwise.  I know of nothing else that could have caused this and it has never happened before.
Pruritic induration with maximum diameter of 4-5 in. Began within 24 hours of MENVEO. Area feels warm to touch. No vesicular lesions present. Placed on oral hydroxyzine TID and steroid cream.
Information has been received from a physician concerning a 9 year old male who on 01-MAY-2000 was vaccinated with a first dose of VARIVAX. At 9:50 am on 26-SEP-2008, the patient was vaccinated in the left arm with a second dose of VARIVAX (lot # 661645/0972X) with diluent (lot # 4017X). Illness at time of vaccination included insect bite and furuncle in the left thigh. Concomitant therapy included FLUMIST in the nasal at the same time. On 27-SEP-2008, the patient experienced red and swelling at injection site on the left arm measuring over 3.5 inches 2.5 inches. The area was warm to touch. The patient had no respiratory difficulty. The patient complained of tenderness at the injection site. On unspecified date the patient was treated with Benadryl, oral administration, per 6 hours and cool compresses to injection site. Subsequently, the patient had a trace of red area and monitored for swelling and redness. On 29-SEP-2008, the patient recovered. This is one of several reports from the same source. No further information is available.
PATIENT RECIEVED VACCINATION ON 01/15/09. HAD RED WELT AT INJECTION SITE APPROXIMATELY 3 INCHES IN DIAMETER WITHIN 24 HOURS. WELT PROGRESSED TO 6 INCHES IN DIAMETER OVER THE NEXT 48 HOURS, THEN REDUCED TO A SMALL WELT AT THE TIME OF CALL TO ADMINISTRATOR ON 01/20/09.
Starting 8 hours after shot: body aches, extreme chills/shivering,  headache,  exhaustion, Lasted from 9pm on day of vaccine until 7pm next day, so 22 hours. Then I felt totally normal again
Left arm swelling at Tdap site x 2 days, since shortly after administered. Arm is red and swollen but not painful. Treated with prn cool compress, ibuprofen, and Benadryl. Given prophylactic clindamycin 300mg TID.
Gardasil used to treat Recurrent Respiratory Papillomatosis; Literature Report:   Information has been received from the authors of a literature, titled as stated above, referring to a 12 years old female patient. The patient was diagnosed with juvenile onset recurrent respiratory papillomatosis (RRP). The affected sites included larynx, tracheal and pulmonary. The surgical interval between excisions for papilloma was 1-4 weeks. Numerous adjuvant treatments had been administered, including localized cidofovir, systemic interferon, systemic propranolol and systemic celecoxib.  On an unknown date, the patient was also vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, route, dose, frequency, lot number and expiration date unknown) to treat juvenile onset RRP (product use in unapproved indication).  A copy of the published article is attached as further documentation of the patient's experience.
Rash on right side of body. Itching and pus filled blisters under right breast area and upper right arm.
TAKING VIVOTIF WHILE ON THE TRIP TO THE ENDEMIC AREA; This spontaneous case report (PVX2019-2372) was received from a consumer on 18-Sep-2019. It described a 27-year-old male consumer who was "taking Vivotif while on the trip to the endemic area" (PT: Inappropriate schedule of product administration), while being on Vivotif (take one dose every other day) for typhoid prophylaxis.  Case report: The consumer started taking Vivotif doses form an unknown date. It was reported that, he was still taking doses, while he was midway through his trip to the endemic area.  Action taken with Vivotif with respect to the event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "taking Vivotif while on the trip to the endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "taking Vivotif while on the trip to the endemic area" was considered as not applicable.
Body ache, head ache, itching, whelps to wrist, stomach,  back, buttocks, shoulders and arms. Patient states she too zyrtec with some relief. Went to ER on 11/03/2023 and was treated and told to take Benadryl. Patient states ER Dr. was unable to tell whether the Spikevax caused the whelps/itching.  Patient states she has appointment with PMD.
After receiving the 1st dose of Moderna Covid-19 vaccine about 11:30 am on 2/18/21: 1. About 4:00 pm that same afternoon I started to feel some soreness around the injection area and a slight headache. 2. By about 7:00 pm that same evening the soreness and headache had increased and I was feeling general body achiness. It was much worse sitting or standing so I ate a small dinner and then went to bed to lie down. I felt much better to be prone. 3. I normally go to sleep between 11 pm to 1 am but fell asleep around 8:20 pm. When I go to sleep that early I often wake up during the night and will be awake for a few hours before falling asleep again. That is what happened. I slept about 3.5 to 4 hours then was up for about 3 hours then went to sleep again for about 3 to 4 hours. I think I got about 7 hours sleep which was good since my typical is about 6 hours. 4. I woke up the morning of one day after and still felt the same, that is, my arm was very sore, and somewhat swollen, around the injection area, and I had a headache and general body achiness, and it was worse sitting and standing and much better lying down prone. Other than getting something to eat I stayed prone most of the day until later afternoon when I did manage to be sitting up for several hours. 5. By the time I went to sleep that night, again a little earlier than normal but maybe around 10 pm, my arm was very sore, and pretty swollen, around the injection area, and I had a headache and general body achiness. 6. By the time I awoke on the morning two days after the vaccination, that is 2/20/21, everything was reduced but still there, that is, my arm was still sore and swollen but much less from the peak, and I had a mild headache and the body aches were pretty much gone. 7. By the time I awoke on the morning of 3 days after, that is 2/21/21, I felt normal.
-After review of vaccination, it was noticed that the vaccine that was administered to this patient was actually prepared on 11/1 and was therefore expired.  -Medication had been refrigerated.  -No known patient harm has come from this event.
"Moderna COVID-19 Vaccine EUA" did well until day 8 about 2pm my arm was itching below injection site, red welp, warm to touch, swelling  about quarter size, applied benadryl cream, took zyrtec.  On day 9 itching and welp is better but more redness about half dollar size, took benadryl and applied ice pack . Getting better each day will continue antihistamines, ice pack and tylenol as needed. Will follow up with provider if no improvement
Bilateral intense pain in both upper quadriceps; Bilateral intense pain  in both wrists; Bilateral intense pain in both shoulders; Bilateral intense pain in both psoas muscles; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 28Mar2021 at 10:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and multiple spinal fusions. The patient had known allergies to fluoroquinolones such as ciprofloxacin(MANUFACTURER UNKNOWN) which was taken for an unknown indication on an unknown date and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2weeks of vaccination which was unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 12:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. On 30Mar2021, the patient experienced bilateral intense pain in both wrists, bilateral intense pain in both shoulders, bilateral intense pain in both upper quadriceps and psoas muscles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of wrist pain, shoulder pain, pain in upper quadriceps and psoas muscle pain and included treatment with physical therapy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bilateral intense pain in both wrists, bilateral intense pain in both shoulders, bilateral intense pain in both upper quadriceps and psoas muscles was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
A physician reported that an 81 year old female received an injection of Pnu-Imune 23 on 4/19/00. Immediately, post vax, she developed an injection site reaction characterized by redness, pain and swelling. This is 1 of 2 pts from this facility, who experienced this event following receipt of Pnu-Imune 23, lot 458744.
Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.; No adverse event; dose administered after 12 hours post puncture.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.), PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2022 at 10:12 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Nov-2022 at 10:12 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.), PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.) and PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.).    Concomitant products were not reported.  It was reported that the vial was individual vial with 2.5ml size, vial was initially stored in the refrigerator on 08-Nov-2022. Vial was first punctured on 09-Nov-2022 at 08.00 AM. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The vial was not exposed to room temperature for more than 24 hours.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live follow-up received: IRD has been updated.