chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old.; This non-serious spontaneous safety report with reference #02144115 was received by a partner on 08-APR-2022 and forwarded on 11-APR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old" is assessed as not applicable due to the nature of the event.  Further information is expected.   FOLLOW-UP information was received by a partner on 18-APR-2022 and forwarded on 19-APR-2022 from a health care professional. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event "9 month old was given VAXELIS at 2 months old and 4 months old, and then given PEDIARIX at 6 months old"  remains not applicable due to the nature of the event.  Further information is expected.  SIGNIFICANT FOLLOW-UP information was received on 18-MAY-2022 from a health care professional. The case is maintained as non-serious.   It was reported that no adverse reactions occurred due to the interchange of vaccines (event onset date 06-JAN-2022).  Patient's concomitant vaccinations at 6 months appointment were Prevnar, RotaTeq, and Influenza along with Pediarix.  Further information is expected.
an adult dose of Havrix was administered to a child; an adult dose of Havrix was administered to a child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 3-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 18-OCT-2023, the patient received Havrix 1440 adult. On 18-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult dose of Havrix was administered to a child) and adult product administered to child (Verbatim: an adult dose of Havrix was administered to a child). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The patient age was 3 years 1 month. Nurse reported that an adult dose of Havrix was administered to a child, which led to overdose and adult product administered to child. The reporter consented to follow up.
Pain at injection site, decreased range of motion, PCP believes to be bursitis. Still ongoing pain 10/26/12.
Severe neck and shoulder pain (right-side). Now shoulder nerve pain and numbness in hand.
Experienced expected side effects as described during first 48 hours (flushed, headache, night chills/sweats, fatigue, body aches/discomfort). Intense throat pain 48 hours after shot (sensitivity and pain at back of tongue). RA flare starting on day 3 after shot. Continued loss of appetite,  fatigue, insomnia, joint swelling and pain 9+ days after shot. At the time of vaccine and after, regular RA meds (sulfasalazine) were not discontinued.
In mid April, I started to have numbness in my fingers on both hands and it started to spread into my arms, chest, and back. I saw a surgeon and a neurologist when I went to the hospital.  I was diagnosed transmyelitis. I still have numbness and tingling in my hands and down my legs.
4:30pm Patient c/o feeling dizziness.  Patient requested water, was given water as per request and tolerated.  4:35pm Patient reported feeling better.  Patient was advised to call 911 or contact primary care physician if still having symptoms.  Patient is alert, verbal, local and able to make needs known.  Verbalized understanding
Bell's palsy; loss of hearing; Shingles; Information has been received regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date ("shortly after receiving the vaccine"), the pt experienced singles, loss of hearing and Bell's palsy. It was reported that as a consequence of zoster vaccine live (ZOSTAVAX), the pt suffered sustained, severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, due to resulting physical limitations, that were not present prior to vaccination, and seriousness of his condition. Moreover, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations, an others. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, Bell's palsy and loss of hearing were considered to be medically significant events. Additionally, all the reported events were considered to be disabling.
Slowed me up/have always been pretty active and nowhas cut back on my activities; Knee is bothering her while walking/ Pain Left Knee; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Slowed me up/have always been pretty active and nowhas cut back on my activities) and ARTHRALGIA (Knee is bothering her while walking/ Pain Left Knee) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Previously administered products included for an unreported indication: CORTISONE (2 cortisone shots in her groin area.) on 18-Mar-2021.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ARTHRALGIA (Knee is bothering her while walking/ Pain Left Knee). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Slowed me up/have always been pretty active and nowhas cut back on my activities). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Slowed me up/have always been pretty active and nowhas cut back on my activities) outcome was unknown and ARTHRALGIA (Knee is bothering her while walking/ Pain Left Knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Patient stated that she will be having left hip replacement on 21-Aug-2021.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 22-Jul-2021 contains no significant information. FU amended for the missed event from follow-up 1 which has been added. On 05-Jun-2021: Follow-up received on 5-jun-2021 contains NNI
Day after vaccination awoke with pain in right knee. Brown discoloration developed from knee to toes on lateral side of leg. Leg is slightly cooler than opposite leg.
This spontaneous report as received from a nurse refers to a 13 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a 0.5 ml dose of (Lot # 0414AE; exp date 27-FEB-2014) VARIVAX (Merck) on 03-JUL-2012. No other co-suspects were reported. There was no concomitant medication. On an unknown date the patient experienced an injection site reaction after being administered the vaccine. The patient sought unspecified medical attention. Treatment was provided by observing the patient since the vaccination. The patient does annual check ups. At the time of the report the patient was recovering. The relatedness for injection site reaction is unknown for VARIVAX (Merck). Lot check has been requested by the nurse. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered pharmacist refers to 2 or 3 patients who on an unknown date, were vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that in the past, on an unknown date, the patient had a slight rash at the injection site after receiving ZOSTAVAX. No treatment information was reported. The rash resolved soon afterwards on an unspecified date. It was unspecified if the patients sought medical attention. The relatedness for 2 or 3 patients had a slight rash at the injection site after receiving ZOSTAVAX was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information do distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
101-102 temp for 4-6 hr. fussy for 24 hr- inconsolable for 30 min. red local rxn from inject site to knee for 8 hr. Tx w/ APAP
AFTER GIVING THE MODERNA COVID VACCINE THE PATIENT REPORTED FEELING TINGLING IN HER JOINTS AND SLIGHT BLURRED VISION.  THE PATIENT WAITED IN THE PHARMACY AREA FOR 1 HOUR AND DID NOT FEEL ANY BETTER OR ANY WORSE. SHE DECIDED TO GO HOME AND I TOLD HER TO SEEK MEDICAL ATTENTION IF SYMTOMS GOT WORSE.
This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 55-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Previously administered products included SHINGRIX (1st dose received on 29th January 2018 with muscle ache, chills and shakes. (This case is linked with US2018071935)). On 23rd April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, 1 day 4 hrs after receiving SHINGRIX, the patient experienced nausea. On 23rd April 2018, the patient experienced muscle pain, sweating, body odor, chills and tremor. In April 2018, the outcome of the sweating, body odor, chills and tremor were recovered/resolved. On an unknown date, the outcome of the muscle pain and nausea were recovering/resolving. The reporter considered the muscle pain, nausea, sweating, body odor, chills and tremor to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included Vitamins. The patient experienced muscle ache, chills and shakes as she did with the first dose of SHINGRIX. After vaccination with SHINGRIX, the patient experienced tremors after 10 hours, sweating and skin odour after 12 hours. The patient could not explain what the body odor smelt like other than it was a strange odor coming from her entire body. The patient had to take a shower to get rid of the odor. The other side effects from vaccination day seemed to resolve themselves like when a fever breaks. The nausea and muscle ache was getting better at the day of reporting. The physician reported that the patient was in good health and had no health problems.
Swollen arm of soft tissue at injection site with arm and shoulder pain. Unknown time of onset as information was given from a different clinic. I asked when symptoms started and clinic staff said it started after the injection and has progressively gotten worse.
Developed a serious bruise at injection site overnight.  Bruise was accompanied by severe arm muscle pain.
Nurse used Diptheria/Tetanus for Tubersol for PPD for skin testing.
See previous field for description of event which took place almost 3 months after vaccination booster shot. Intestinal infection - viral? It passed by itself, resolved after a few days.
Patient was administered ACTHIB vaccine approximately 1430 on 11/03/2009. According to RN, patient had an anaphylactic reaction within 1 hour of vaccine. However, the patient was started on PCA DILAUDID that morning; therefore anaphylaxis due to DILAUDID cannot be ruled out. Patient was given Methylprednisolone 125 mg IVP around 1500 and again at 22:00. Patient was given cimetidine 300 mg IV once at 15:00. Pt recovered from anaphylaxis with this regimen but had residual symptoms. She complained of itching for 4 days and was given diphenhydramine 12.5 mg prn to treat. Patient was switched from DILAUDID to morphine due to possibility that DILAUDID caused the reaction. There was no cross reactivity reported and she has received morphine for several days with no adverse reactions, DILAUDID was not reintroduced.
Ringing in ears. Seems to be worse on left side. Pain in left inner ear.
get very sick right after every year; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a female patient of unknown age who get very sick right after every year (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient had got very sick right after every year (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Breakthrough case admission after three vaccines Pfizer 3/12/21 Lot# EN6199;  Pfizer 3/31/21 Lot# ER8733;  Pfizer 1/17/22 Lot# FJ6369
Moderna COVID-19 Vaccine EUA Woke up around 2300 shaking with chills, turned heat up, woke up around 0300 feeling feverish, 101 degree temperature, slight headache, soreness in arm
rash sx urticaria-severe itch;tx DPH, po & dermatox lotion starch & soda baths-next day went back to MD for DPH-used clorox @ home to clear up rash;
Pt was sitting and doing paper work, and she had no pain. About 4:15 PM she experienced severe pain in the right hip towards the lower back area. The pain was severe enough that walking was difficult. The pain lasted 2 hours, and there were no other symptoms.
Patient stated they had not been previously vaccinated for Covid-19 and attested to that on their consent form. After giving the shot and patient left, we were attempting to bill it to insurance and it rejected with a code of "second dose in series not covered" I called and asked him if he for sure had not gotten a covid vaccine in the past and he stated he had not. I said I would get back to him.  I then looked him up on the Immunization Registry and he has gotten 3 Pfizer doses and 1 Moderna vaccine at other locations. I have tried to called him to discuss with him the fact that he should not be seeking further vaccination and has exceeded the recommended doses for covid-19 and he has not returned my call as of 9/23/21 at 5:15 pm.   His covid vaccination history is as follows: Pfizer 1 of 3 3/18/21 Pfizer 2 of 3 4/8/21 Pfizer 3 of 3 8/20/21 Moderna 1 of 1 9/18/21
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported on adverse reactions.
Patient reported to the pharmacist that she experienced a lot of bleeding immediately after vaccine administration and developed bruising the next day that lasted up to 3 weeks. Patient has never bled or bruised from previous vaccinations and was concerned this happened to her. Patient did not seek any treatment. Pharmacist explained to patient that this can be a normal reaction to a vaccine but she was adamant that this reaction was unusual for her. Pharmacist told her she would report it.
This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 47-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, pain, fever and dry skin. On 17th June 2018, the outcome of the extensive swelling of vaccinated limb was recovered/resolved. On an unknown date, the outcome of the erythema, pain, fever and dry skin were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, pain, fever and dry skin to be related to SHINGRIX. Additional details were received as follows: The patient had multiple other health issues. It was unknown if the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if health care professional consider the event to be life threatening. It was unknown if health care professional consider the event(s) to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the event require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. The reporter received a text that the patient needed her second shingle shot. The patient was insisted to take SHINGRIX. The patient experienced red dry area, pain unusual, feverish for two days and swelling to below elbow.
Hep-B vaccine given in right deltoid. Hep-A vaccine given in left deltoid. The next AM, had erythema and tenderness from left deltoid down. Worsened over the next 24 hours. Seen in ER and dx'd with cellulitis. Treated with IM Amox. and po flu. Seen the next day in clinic with regression of erythema.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were reported as follows: Age at vaccination was not reported. The 1st dose of SHINGRIX did not even cause tender arm which was very unusual for the patient. The patient experienced red and sore of the upper arm which lasted for 4 to 5 days after receiving 2nd shot. The patient was concerned whether the 1st dose of SHINGRIX was effective or if for some reason something went wrong. This case has been linked with case US2018GSK185955, reported by the same reporter.
Localized redness, swelling, discomfort/pain, and itchiness at site of injection. Seen in office today. 1 cm diam ecchymosis at injection site 2 cm surrounding area of inflammation.
Nine days later, I got  rash and it lasted less than a week. It was raised, it was red but it was not itchy. It expanded to about 4 inches or so and then it stopped.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022).    No concomitant product use was reported.   Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.   No treatment information was provided.
Patient received a flu shot in left arm on 10/15/2017. Beginning the next day, the arm near injection site became very sore with a little numbness. The pain and lack of range of motion did not get any better. On 10/25/2017, saw doctor and was put on an 8 days course of oral prednisone. Patient felt better, but pain came back after steroid course was done.
got worse throughout the night; shortness of breath; kept waking her up from her sleep; coughing uncontrollably; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Panic disorder, Allergic reaction to drug (Allergic to steroids) and Latex allergy. Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]) and CLONAZEPAM for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue). The patient was treated with PROMETHAZINE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CONDITION AGGRAVATED (got worse throughout the night), DYSPNOEA (shortness of breath), SLEEP DISORDER (kept waking her up from her sleep), COUGH (coughing uncontrollably) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient reported the following symptoms one day after shot given -> headache, "pain in bones", fast heart, back pain. RPh recommended patient see MD if chest pain/fast heart and try TYLENOL for "aching".